protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT00555971 | 4 | DATA MANAGEMENT AND STATISTICAL METHODS | 4 DATA MANAGEMENT AND STATISTICAL METHODS
Safety Assessment: Investigators will enter information required by the protocol into the Case Report Forms (CRFs). Non-obvious errors or omissions will be entered on Data Query Forms, which will be returned to the investigational site for resolution. The assessment of safety ... | [
"Safety Assessment:",
"Statistical Methods:",
"Interim Analysis",
"Sample Size Calculation:"
] |
NCT00555971 | 5 | REFERENCES | 5 REFERENCES
CITATIONS - 1) Stevenson DD, Simon RA, Mathison DA, Christiansen SC. Montelukast is only partially effective in inhibiting aspirin responses in aspirin sensitive asthmatics. Ann Allergy Asthma Immunol 2000; 85: 477. - 2) Pauls JD, Simon RA, Daffern PJ, Stevenson DD. Lack of effect of the 5-Lipoxygenase in... | [
"CITATIONS",
"Signature of Investigator(s) and Study Personnel type/print name (Investigator) David M. Lang, MD signature date type/print name (Statistician) signature date type/print name Head of investigational site signature date type/print name Medical Director signature date type/print name (Regional Scienti... |
NCT00810446 | 1 | Objectives | 1. Objectives This survey is a drug use investigation to investigate the clinical course of patients who received drugs for the treatment of HIV infection, which are the reexamination products, understand the occurrence of adverse events under actual use conditions and figure out factors affecting safety, in addition t... | [] |
NCT00810446 | 2 | Target Patients and Target Drugs | 2. Target Patients and Target Drugs The patients of this survey are all patients who are prescribed with drugs for the treatment of HIV infection (see P. 6) which are subject to reexamination at limited sites. | [] |
NCT00810446 | 3 | Survey Period | 3. Survey Period - 1) In principle, the drugs for the treatment of HIV infection are designated as orphan drugs, and the reexamination period for each drug is 10 years as a rule (see P. 6). - 2) The end date of patient registration for the drug use investigation is as mentioned in page 6. - 3) This survey will enroll p... | [] |
NCT00810446 | 4 | Procedures | 4. Procedures This survey is a joint survey by companies having drugs for the treatment of HIV infection which are subject to reexamination (hereinafter referred to as "joint survey participating companies") and will be outsourced to a contracted company [CMIC-PMS Co., Ltd. (hereinafter referred to as "CRO")].
1) Requ... | [
"1) Request for the survey and a contract",
"2) Method for data collection",
"3) Patient registration",
"4) Points to consider for data entry, revision, and review",
"5) Retention of the original CRF"
] |
NCT00810446 | 5 | Survey Items | 5. Survey Items - 1) Common items (CRF for the drug use investigation) - (1) Background - (2) Prescribed anti-HIV drug - (3) Prescribed concomitant medications (including drugs for the treatment of HIV-related diseases) - (4) Concomitant therapies - (5) Patient's outcome (at the discontinuation of the survey) - (6) HIV... | [] |
NCT00810446 | 6 | Others | 6. Others - 1) Prior to utilizing drugs for the treatment of HIV infection, the investigator should fully explain the details of ADRs and other relevant matters to patients, confirm their consent for the treatment and record in their medical records that consent has been obtained. When giving the explanation to the pat... | [] |
NCT00810446 | 7 | Where to contact (Inquiries on the contents of the contract, protocol and CRF, registration, collection of the CRF, and data clarification) | 7. Where to contact (Inquiries on the contents of the contract, protocol and CRF, registration, collection of the CRF, and data clarification) | CRO | Contact information | |--------------------|--------------------------------------| | CMIC-PMS Co., Ltd. | 1-1-1 Shibaura, Minato-ku, Tokyo | | | Tel: 0120-204393Fax: 01... | [] |
NCT00810446 | 8 | List of Contracted Joint Survey Companies (including distributing companies) | 8. List of Contracted Joint Survey Companies (including distributing companies) | Joint survey participating companies (randomorder) | Contact information | |--------------------------------------------------------|---------------------------------------------------| | Safety Management Department | GSK Building, 4-6-1... | [
"Drugs for the treatment of HIV infection participating in the HRD joint survey",
"Anti-HIV drugs",
"Drugs for the treatment of HIV-related diseases",
"Procedures for Implementation of the HRD Joint Survey",
"Procedures for Notifying ADRs, etc.",
"(Sites) CRO [CMIC-PMS Co., Ltd.]"
] |
NCT01192568 | 2 | SYNOPSIS | 2 SYNOPSIS
Sponsor: AbbVie Inc.
Name of Finished Product: oxybutynin chloride gel
Name of Active Ingredient: oxybutynin chloride
Study Title: A Two-part, Multicenter, Dose-titration Study Evaluating the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Oxybutynin Chloride 10% Gel for the Treatment of Detr... | [
"Sponsor:",
"Name of Finished Product:",
"Name of Active Ingredient:",
"Study Title:",
"Study Number:",
"Primary Objectives:",
"Secondary Objectives (for Pre-Amendment 3 and Post-Amendment 3):",
"Study Design:",
"Study Population:",
"Test Product, Dose, and Mode of Administration:",
"Comparator ... |
NCT01192568 | 4 | LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS | 4 LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS | AE | adverse event | |--------|--------------------------------------------------------------------------------------------------------------------------| | ANCOVA | analysis of covariance | | CFB | change from baseline | | CFR | Code of Federal Regulations | | CIC | c... | [] |
NCT01192568 | 5 | ETHICS | 5 ETHICS | [] |
NCT01192568 | 5.1 | Institutional Review Board or Ethics Committee | 5.1 Institutional Review Board or Ethics Committee The protocol and supporting documents for this study will be reviewed and approved by an appropriately constituted institutional review board (IRB) or ethics committee (EC) prior to study initiation. All reviews and approvals will be in accordance with GCP as contained... | [] |
NCT01192568 | 5.2 | Ethical Conduct of Study | 5.2 Ethical Conduct of Study The study will be conducted in accordance with GCP as contained in ICH guidelines and US CFR governing the protection of human patients (Title 21, Part 50) and the obligations of clinical investigators (Title 21, Part 312.60 through 312.69). The study will also be conducted in accordance wi... | [] |
NCT01192568 | 5.3 | Patient Information and Consent | 5.3 Patient Information and Consent The investigator will ensure that each patient will provide assent (if applicable and according to IRB regulations) and their parent(s) or legal guardian(s) will sign the written informed consent form in accordance with applicable regulations. Patients and their parent(s) or legal gu... | [] |
NCT01192568 | 5.4 | Authorization to Disclose Protected Health Information | 5.4 Authorization to Disclose Protected Health Information If required under HIPAA regulations, patients and their parent(s) or legal guardian(s) will be informed of the following information: - The sponsor of the study - Any contractors that may be involved in the study - The purpose of the protected health informatio... | [] |
NCT01192568 | 6 | INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE | 6 INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE AbbVie Inc. is the sponsor of this study. On the approval date of this amended protocol, the administrative structure and the external organizations supporting the study were as follows: Sponsor: AbbVie Inc. Biostatistician: \ PhD Medical Safety Physician: PhD 1 North W... | [] |
NCT01192568 | 7 | INTRODUCTION | 7 INTRODUCTION Oxybutynin chloride is a well-known anticholinergic and antispasmodic agent that has gained widespread use in the pharmacological management of overactive bladder over the past 3 decades. It has shown efficacy, safety, and tolerability in the treatment of both adult and pediatric patients. Oxybutynin is ... | [] |
NCT01192568 | 8 | STUDY OBJECTIVES | 8 STUDY OBJECTIVES | [] |
NCT01192568 | 8.1 | Primary Objectives | 8.1 Primary Objectives The primary objectives of this study are: - Pre-amendment 3: To evaluate the efficacy of daily treatment with oxybutynin chloride gel compared to placebo in pediatric patients during the first 6 weeks of a 14-week treatment period. - Post-amendment 3: To evaluate the efficacy of daily treatment w... | [] |
NCT01192568 | 8.2 | Secondary Objectives | 8.2 Secondary Objectives The secondary objectives of this study are to evaluate the pharmacokinetics, pharmacodynamics, safety, and skin tolerability of oxybutynin chloride gel in pediatric patients. Confidential Page 23 of 74 | [] |
NCT01192568 | 9 | INVESTIGATIONAL PLAN | 9 INVESTIGATIONAL PLAN | [] |
NCT01192568 | 9.1 | Overall Study Design and Plan | 9.1 Overall Study Design and Plan This study was initiated as a double-blind, placebo-controlled study with an open-label extension, and is now amended to continuing to enroll patients under only open-label treatment. Pre-Amendment 3, patients ages 6 to >17 years, were randomly assigned 1:1 to receive doubleblind oxybu... | [] |
NCT01192568 | 9.3.1 | Inclusion Criteria | 9.3.1 Inclusion Criteria Patients will be considered for inclusion in the study if they meet all of the following criteria: - INOL. Are 3 years-of-age (6 years for Pre-Amendment 3) to < 17 years-of age, at the time of screening - INO2. Have a diagnosis of detrusor overactivity associated with a neurological condition -... | [] |
NCT01192568 | 9.3.2 | Exclusion Criteria | 9.3.2 Exclusion Criteria Patient will be excluded from participation if they meet any of the following criteria: - EX01. Are pregnant or lactating - EX02. Have a patient-reported average CIC of more than 6 times per 24-hour period during the screening period, as captured by the 2-day urinary diary - EX03. Have 1 or mor... | [] |
NCT01192568 | 9.3.3 | Patient Identification | 9.3.3 Patient Identification Patient study identification numbers will be assigned at the Screening Visit. Patient numbers will be consecutive at each study site beginning with 001. Patient numbers will consist of the site number (3 digits) followed by the patient number (3 digits) at that site. Patient identification ... | [] |
NCT01192568 | 9.3.4 | Removal of Patients from Treatment or Assessment | 9.3.4 Removal of Patients from Treatment or Assessment An attempt will be made to identify and follow every patient enrolled in the study through to completion. If a patient withdraws, or is withdrawn from the study by the investigator, the reason and circumstances for such early termination must be fully documented. P... | [] |
NCT01192568 | 9.4 | Study Treatments | 9.4 Study Treatments | [] |
NCT01192568 | 9.4.1 | Treatments Administered | 9.4.1 Treatments Administered Pre-Amendment 3, patients were randomized to receive oxybutynin chloride gel or placebo during the 6-week double-blind treatment period, and all patients received oxybutynin chloride gel during the 8-week open-label treatment period. Patients randomized to double- blind oxybutynin chloride... | [] |
NCT01192568 | 9.4.2 | Identity of Study Treatment | 9.4.2 Identity of Study Treatment | [] |
NCT01192568 | 9.4.2.1 | Description of Study Treatment | 9.4.2.1 Description of Study Treatment Oxybutynin chloride gel is a pH 6.0 clear, colorless, hydroalcoholic gel containing 100 mg of oxybutynin hydrochloride salt per gram of gel. Each gram is designed to deliver approximately 4 mg oxybutynin to the systemic circulation. Inactive ingredients are alcohol, USP; glycerin,... | [] |
NCT01192568 | 9.4.2.2 | Packaging, Labeling, and Dispensing | 9.4.2.2 Packaging, Labeling, and Dispensing The study treatment will be packaged in individual patient cartons containing a sufficient supply of sachets for the completion of the treatment period, plus an additional amount for supplies that are mishandled. Each patient carton will be color-coded by dose level (0.5, 0.7... | [] |
NCT01192568 | 9.4.2.3 | Storage and Accountability | 9.4.2.3 Storage and Accountability The study treatment will be stored in a secure location at controlled room temperature, 20°C to 25°C/68° to 77°F (with excursions allowed between 15°C and 30°C/59°F and 86°F) and away from direct sunlight. The investigator shall maintain accurate study treatment inventory records, inc... | [] |
NCT01192568 | 9.4.3 | Method of Assigning Patients to Treatment Groups | 9.4.3 Method of Assigning Patients to Treatment Groups Pre-Amendment 3, patients were randomized to oxybutynin chloride gel or placebo treatment in a 1:1 ratio within each stratification level, using an interactive voice recognition system (IVRS). Enrollment was stratified based on sex, age, and weight. Stratification ... | [] |
NCT01192568 | 9.4.4 | Selection of Doses and Timing of Administration in the Study | 9.4.4 Selection of Doses and Timing of Administration in the Study Pre-Amendment 3, patients were randomized to receive oxybutynin chloride gel or placebo during the 6-week double-blind treatment period, and all patients received oxybutynin chloride gel during the 8-week open-label treatment period. Patients randomized... | [] |
NCT01192568 | 9.4.5 | Blinding | 9.4.5 Blinding Pre-Amendment 3, the study involved double-blind treatment over the first 6 weeks, with subsequent open-label treatment. Blinding of this portion of the study will remain intact during Post-Amendment 3. Post-Amendment 3, the study is entirely open-label. | [] |
NCT01192568 | 9.4.6 | Prior and Concomitant Therapy | 9.4.6 Prior and Concomitant Therapy Patients may not use concomitant medications that may affect detrusor activity, including anticholinergic agents (eg, oxybutynin, propantheline, dicyclomine, flavoxate, hyoscyamine, tolterodine, darifenacin), tricyclic antidepressants (eg, imipramine, doxepin, desipramine, nortriptyl... | [] |
NCT01192568 | 9.4.7 | Treatment Compliance | 9.4.7 Treatment Compliance Compliance with the assigned study treatment regimen will be assessed by comparing the number of sachets expected to be used as based on the total number of treatment days with the actual number used (expressed as percentage of use/expected). Compliance will be assessed and recorded at each c... | [] |
NCT01192568 | 9.5 | Study Activities | 9.5 Study Activities The following sections (Sections 9.5.1 to 9.5.4) provide details of the study activities Post-Amendment 3 (ie, only open-label enrollment). Note that alterations from prior details are shown in bold italics and are further enumerated in the accompanying Summary of Changes document. A schedule of ev... | [] |
NCT01192568 | 9.5.1 | Screening Period (5 to 13 Days) | 9.5.1 Screening Period (5 to 13 Days) The screening period will occur from Day -13 to Day -5 and will include 1 clinic visit, Visit A (Screening Visit), where patients will be considered for inclusion in the study. Following Visit A, all patients taking anticholinergic medications will be asked to complete a 3-day mini... | [] |
NCT01192568 | 9.5.1.1 | Visit A (Screening Visit) | 9.5.1.1 Visit A (Screening Visit) Site personnel will perform the following: - 1. Provide detailed explanation of the study. - 2. Obtain informed consent and assent (if applicable) - 3. Vision screening assessment. Prior to Baseline Visit patients who are < 8 years of age at the time of screening who have not had a vis... | [] |
NCT01192568 | 9.5.2 | Open-label Treatment Period (14 Weeks) | 9.5.2 Open-label Treatment Period (14 Weeks) The 14-week, open-label treatment period will begin at Visit B (Baseline Visit, Week 0 of treatment). Patients should have completed the washout period and the 2-day urinary diary prior to Visit B. If patients continue to meet eligibility criteria at Visit B, a urodynamic ev... | [] |
NCT01192568 | 9.5.2.1 | Visit B (Baseline Visit) (Week 0 of Treatment) | 9.5.2.1 Visit B (Baseline Visit) (Week 0 of Treatment) Site personnel will perform the following activities at Visit B: - 1. Collect and review 2-day urinary diary and data. Patients who accurately complete the 2-day urinary diary but do not meet entry criteria based on number of catheterizations will not undergo furth... | [] |
NCT01192568 | 9.5.2.2 | Visit C (Week 2 of Treatment) Dose Titration Opportunity | 9.5.2.2 Visit C (Week 2 of Treatment) Dose Titration Opportunity Patients will return to the clinic after 2 weeks of treatment for evaluation and a dose titration opportunity. Site personnel will perform the following activities: - 1. Perform study treatment accountability. - 2. Record concomitant medication use. - 3. ... | [] |
NCT01192568 | 9.5.2.3 | Visit D (Week 6 of Treatment) | 9.5.2.3 Visit D (Week 6 of Treatment) Site personnel will perform the following activities at Visit D: - 1. Perform study treatment accountability. - 2. Collect and review 2-day urinary diary and data. - 3. Record concomitant medication use. - 4. Measure and record vital signs (blood pressure, heart rate, respiratory r... | [] |
NCT01192568 | 9.5.2.4 | Visit E (Week 10 of Treatment) | 9.5.2.4 Visit E (Week 10 of Treatment) Site personnel will perform the following activities at Visit E: - 1. Perform study treatment accountability. - 2. Record concomitant medication use. - 3. Measure and record vital signs (blood pressure, heart rate, respiratory rate, and temperature). - 4. Query for adverse events.... | [] |
NCT01192568 | 9.5.2.5 | Visit F (Week 14 of Treatment) or Early Termination | 9.5.2.5 Visit F (Week 14 of Treatment) or Early Termination Visit F will be the end of the open-label treatment period. Patients will undergo evaluation by site personnel who will perform the following activities: - 1. Collect remaining study treatment and perform study treatment accountability. - 2. Record concomitant... | [] |
NCT01192568 | 9.5.3 | Exit/Early Termination Visit | 9.5.3 Exit/Early Termination Visit Study site personnel will make every attempt to follow the progress of every patient admitted to the study through to study completion. If a patient fails to return for a scheduled visit, a reasonable effort should be made to contact the patient and ascertain the reason(s) for not ret... | [] |
NCT01192568 | 9.5.4 | Early Termination Activities | 9.5.4 Early Termination Activities Upon patient withdrawal/early discontinuation from the study, all evaluations scheduled at Visit F (Week 14 of treatment) should be completed at the termination visit. If the early termination visit occurs immediately after a visit in which a diary had been previously dispensed, the d... | [] |
NCT01192568 | 9.6 | Efficacy Assessment | 9.6 Efficacy Assessment The efficacy endpoints of the study will be evaluated based on information derived from the 2-day urinary diaries and urodynamic assessments recorded at baseline and during the treatment period. | [] |
NCT01192568 | 9.6.1 | Urinary Diary | 9.6.1 Urinary Diary The urinary diaries will be completed by each patient/caregiver during the week before Visit B and Visit D. The 2-day urinary diary will be used to collect information for the parameters listed below. A sample urinary diary is provided in Appendix 3. - Number of catheterizations per day - Volume of ... | [] |
NCT01192568 | 9.6.2 | Efficacy Variables | 9.6.2 Efficacy Variables | [] |
NCT01192568 | 9.6.2.1 | Primary Efficacy Variable | 9.6.2.1 Primary Efficacy Variable The primary efficacy endpoint is the change from baseline (CFB) to Week 6 of treatment or the last observation carried forward (LOCF) in the percentage of catheterizations without a leaking accident as recorded in the 2-day urinary diary. | [] |
NCT01192568 | 9.6.2.2 | Secondary Efficacy Variables | 9.6.2.2 Secondary Efficacy Variables Secondary endpoints include the CFB to Week 6 of treatment in the following (calculated from the 2-day urinary diary data): - Average volume of urine collected per catheterization (for Pre-Amendment 3 population only); - Average volume of urine collected at first (morning awakening)... | [] |
NCT01192568 | 9.6.2.3 | Urodynamic Variables | 9.6.2.3 Urodynamic Variables Pharmacodynamics will be assessed for treatment under the Pre-Amendment 3 double-blind phase, treatment under the Post-Amendment 3 open-label phase, and both groups aggregated where appropriate. Pharmacodynamics will be based on urodynamic testing. The following parameters will be evaluated... | [] |
NCT01192568 | 9.7 | Safety Variables | 9.7 Safety Variables Analyses and summaries will be performed for treatment under the Pre-Amendment 3 doubleblind phase, the Pre-Amendment 3 open-label phase, and the Post-Amendment 3 open-label phase, with groups aggregated where appropriate. Patients must be evaluated by a physician or an appropriately trained health... | [] |
NCT01192568 | 9.7.1 | Adverse Events | 9.7.1 Adverse Events An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal labo... | [
"Examples of AEs are as follows:"
] |
NCT01192568 | 9.7.1.1 | Causality Assessment | 9.7.1.1 Causality Assessment For each AE, the investigator must provide an assessment of causal relationship to the study treatment. The causality assessment must be recorded on the eCRF. Causal relationship must be assessed by answering the following question: Is there a reasonable possibility the study treatment caus... | [] |
NCT01192568 | 9.7.1.2 | Severity Assessment | 9.7.1.2 Severity Assessment The investigator will provide an assessment of the severity of each AE by recording a severity rating on the appropriate page of the patient's eCRF. Severity, which is a description of the intensity of manifestation of the AE, is distinct from seriousness, which implies a patient outcome or ... | [] |
NCT01192568 | 9.7.1.3 | Serious Adverse Event | 9.7.1.3 Serious Adverse Event An SAE is any untoward medical occurrence that at any dose: - Results in death - Is life threatening - Requires inpatient hospitalization or prolongation of existing hospitalization - Results in persistent or significant disability/incapacity, or - Is a congenital anomaly/birth defect Impo... | [] |
NCT01192568 | 9.7.1.4 | Reporting Adverse Events and Serious Adverse Events | 9.7.1.4 Reporting Adverse Events and Serious Adverse Events At each visit, patients are to be queried regarding any AEs or SAEs that have occurred since the previous visit. Patients will be asked to volunteer information with a nonleading question such as, "How do you feel since your last visit?" Study site personnel w... | [] |
NCT01192568 | 9.7.1.5 | Immediate Reporting of Serious Adverse Events and Events of Special Interest | 9.7.1.5 Immediate Reporting of Serious Adverse Events and Events of Special Interest The Sponsor is required to inform worldwide regulatory authorities of SAEs that meet specific criteria. Therefore, the Sponsor must be notified immediately regarding any SAE that occurs after informed consent is obtained. Within 24 hou... | [] |
NCT01192568 | 9.7.1.6 | Reporting of Pregnancies Occurring During the Study | 9.7.1.6 Reporting of Pregnancies Occurring During the Study Study site personnel must report every pregnancy from the time the patient signs the ICF until 30 days after the last dose of study treatment. Within 24 hours of learning of the pregnancy, the study site personnel must report the event to Allergen Global Drug ... | [] |
NCT01192568 | 9.7.1.7 | Potential Hy's Law Cases | 9.7.1.7 Potential Hy's Law Cases Criteria for potential Hy's Law cases are as follows: - Alanine Aminotransferase or Aspartate Aminotransferase ≥ 3x upper limit of the normal range (ULN) AND - Total Bilirubin ≥ 2xULN AND - Alkaline Phosphatase < 2xULN Study site personnel must report every patient who meets these poten... | [
"Medical Emergencies and Emergency Protocol Deviations",
"Sponsor Reporting Obligations"
] |
NCT01192568 | 9.7.2 | Clinical Laboratory Evaluations | 9.7.2 Clinical Laboratory Evaluations A blood and urine sample for clinical laboratory evaluations (serum chemistries, hematology, and urinalysis) will be collected from all patients at Visit 1 and at Visit 8 Pre-Amendment 3 and at VisitA and at Visit F Post-Amendment 3. A sample for a urine culture will also be collec... | [] |
NCT01192568 | 9.7.3 | Application Site Erythema Assessment | 9.7.3 Application Site Erythema Assessment Skin reactions at the most recently applied gel application site will be assessed for severity of erythema, at each clinic visit during the treatment period. Other reactions such as itching, edema, papules, patient-reported erythema, etc. will be recorded as AEs using standard... | [] |
NCT01192568 | 9.7.4 | Physical Examination | 9.7.4 Physical Examination A physical examination will be performed at Visits 1 and 8 (Pre-Amendment 3) or Visits A and F (Post-Amendment 3), and will include a review of the following: body as a whole, skin, HEENT, cardiovascular, respiratory, musculoskeletal, neurologic, lymphatic/thyroid, and abdomen. Height and wei... | [] |
NCT01192568 | 9.7.5 | Vital Signs | 9.7.5 Vital Signs Vital signs will be measured at each visit and will include blood pressure (systolic and diastolic), heart rate, respiratory rate, and temperature. 9.8 Other Assessments Other evaluations that will be performed during the study duration include determination of racemic and enantiomeric oxybutynin and ... | [] |
NCT01192568 | 9.8.1 | Determination of R- and S- Oxybutynin and N-desethyloxybutynin Plasma Concentrations | 9.8.1 Determination of R- and S- Oxybutynin and N-desethyloxybutynin Plasma Concentrations Venous blood samples will be collected at Visits 3, 4, 5, and 6 (Pre-Amendment 3) or Visits C, D, and F/ET (Post-Amendment 3) for determination of oxybutynin and N-desethyloxybutynin plasma concentrations. Blood samples (approxim... | [] |
NCT01192568 | 9.8.2 | Medical History | 9.8.2 Medical History The patient's medical history will be taken at Visits 1 and 2 (Pre-Amendment 3) or Visits A and B (Post-Amendment 3) and will include an account of the underlying disease state and its management, including CIC and current medications use. | [] |
NCT01192568 | 9.8.3 | Electrocardiograms | 9.8.3 Electrocardiograms A 12-lead ECG will be recorded at screening. The investigator will evaluate the ECG tracing for any clinically significant abnormalities. | [] |
NCT01192568 | 9.8.4 | Concomitant Medication Use | 9.8.4 Concomitant Medication Use Patients will be queried at each clinic visit concerning the use of medications. Concurrent medications used by the patients will be documented, including the name of the drug, the dose, the frequency, the route of administration, the date of initiation and discontinuation, and the reas... | [] |
NCT01192568 | 9.8.5 | Anticholinergic Symptoms Questionnaire | 9.8.5 Anticholinergic Symptoms Questionnaire Patients/caregivers will be asked to complete an anticholinergic symptoms questionnaire at Visits 2, 6, and 8 (Pre-Amendment 3) or Visits B, C, D, E, and F (Post-Amendment 3). The questionnaire will ask patients/caregivers to describe the intensity of any side effects that m... | [] |
NCT01192568 | 9.8.6 | Vision Symptom Questionnaire | 9.8.6 Vision Symptom Questionnaire Post-Amendment 3, patients/caregivers will be asked to complete a Vision Symptom Questionnaire at Visits B, C, D, E, and F (Appendix 6). The questionnaire will ask patients/caregivers to describe any visual impairment or eye conditions for the patient. Adverse events of vision disorde... | [] |
NCT01192568 | 9.9 | Appropriateness of Measurements | 9.9 Appropriateness of Measurements Urinary diaries are non-invasive tools that provide a record of bladder function in neurogenic and non-neurogenic conditions. The data collected from these diaries give an indication of urinary patterns and severity of symptoms. The urinary diary can be used effectively to assess imp... | [] |
NCT01192568 | 10 | QUALITY CONTROL AND ASSURANCE | 10 QUALITY CONTROL AND ASSURANCE The sponsor will implement and maintain quality control procedures to ensure that this study is conducted, and data are generated, documented, and reported in compliance with the protocol, GCP, and applicable regulatory requirements. The sponsor or designee will routinely conduct monito... | [] |
NCT01192568 | 11 | PLANNED STATISTICAL METHODS | 11 PLANNED STATISTICAL METHODS | [] |
NCT01192568 | 11.1 | Determination of Sample Size | 11.1 Determination of Sample Size Sample size was calculated for the protocol as originally designed (Pre-Amendment 3: doubleblind, placebo-controlled treatment period followed by an open-label extension) as follows: This study was planned to include a minimum of 96 pediatric patients aged 6 to < 17 years who have a di... | [] |
NCT01192568 | 11.2 | Analysis Populations and Databases | 11.2 Analysis Populations and Databases Statistical analysis and data tabulation will be performed using data from the open-label period for patients enrolled after Amendment 3 and the data from the double-blind and open-label periods for patients enrolled prior to Amendment 3 in the following patient populations unles... | [] |
NCT01192568 | 11.3 | Efficacy Parameters | 11.3 Efficacy Parameters The primary efficacy variable for the Post-Amendment 3 open-label period and the Pre-Amendment 3 double-blind period will be the percentage of catheterizations without a leaking accident (continuous variable). The following are secondary continuous efficacy variables that will be calculated: - ... | [] |
NCT01192568 | 11.4 | Descriptive Summaries of Efficacy Parameters | 11.4 Descriptive Summaries of Efficacy Parameters Absolute values and CFB values for all the continuous efficacy parameters will be summarized for all visits, including Week 6 (LOCF), by dose level (0.5, 0.75, and 1.0 g and overall) for the Post-Amendment 3 ITT and PP populations and by treatment group (placebo and oxy... | [] |
NCT01192568 | 11.5 | Statistical Analyses of Efficacy Parameters | 11.5 Statistical Analyses of Efficacy Parameters All analyses will be conducted with SAS® v9.3 or higher using procedures appropriate for the particular analysis. | [] |
NCT01192568 | 11.5.1 | Statistical Analysis of the Primary Efficacy Endpoint | 11.5.1 Statistical Analysis of the Primary Efficacy Endpoint The primary efficacy parameter is the CFB to Week 6 (or LOCF) in the percentage of catheterizations without a leaking accident. The primary efficacy parameter will be analyzed using an analysis of covariance (ANCOVA) model with the baseline measure of the pri... | [] |
NCT01192568 | 11.5.2 | Statistical Analysis of the Secondary Efficacy Endpoints | 11.5.2 Statistical Analysis of the Secondary Efficacy Endpoints For the Post-Amendment 3 ITT population, the analyses of the secondary efficacy parameters will assess the CFB for each variable at Week 6 (LOCF). The significance of the change from baseline on the secondary efficacy measures will be assessed from 2-sided... | [] |
NCT01192568 | 11.5.3 | Additional Analyses | 11.5.3 Additional Analyses The primary and secondary efficacy endpoints will be analyzed at Week 6 LOCF) for each of the per-protocol populations. The analyses will be similar to those described for the primary and secondary efficacy endpoint analyses. The primary and secondary efficacy endpoints will be analyzed at ea... | [] |
NCT01192568 | 11.5.4 | Subgroup Analyses | 11.5.4 Subgroup Analyses The primary and secondary efficacy data analyses will be analyzed separately for age groups, weight group, and sex group for each ITT population, as appropriate. Additionally, analysis of other important subgroups may be provided as well. | [] |
NCT01192568 | 11.6 | Safety Analysis | 11.6 Safety Analysis Safety variables will be summarized for each safety population using descriptive statistics and frequency distributions as defined in the following sections. Summaries will be provided overall and for each age group, weight group, and sex group. | [] |
NCT01192568 | 11.6.1 | Adverse Events | 11.6.1 Adverse Events Key results will be presented for each safety population as follows: - Post-Amendment 3 open-label safety population: by oxybutynin chloride gel dose level and/or overall - Pre-Amendment 3 double-blind safety population: by treatment group and/or treatment and dose level, and/or overall - Pre-Amen... | [] |
NCT01192568 | 11.6.2 | Extent of Exposure | 11.6.2 Extent of Exposure Summaries for duration of exposure for each safety population will be provided by treatment group for the Pre-Amendment 3 double-blind period, and by exposure to oxybutynin chloride gel for each of the Pre-Amendment 3 and Post-Amendment 3 open-label periods and the Pre-Amendment 3 double-blind... | [] |
NCT01192568 | 11.6.3 | Laboratory Evaluations and Abnormalities | 11.6.3 Laboratory Evaluations and Abnormalities Continuous clinical laboratory analytes will be summarized for each safety population by double-blind period treatment group, double-blind treatment/oxybutynin chloride gel sequence, or oxybutynin chloride gel only, as applicable, and by analyte and visit using descriptiv... | [] |
NCT01192568 | 11.6.4 | Vital Signs | 11.6.4 Vital Signs Vital sign measurements will be summarized for each safety population by treatment group, double-blind treatment/ oxybutynin chloride gel sequence, or oxybutynin chloride gel only group, as applicable, and visit using descriptive statistics (mean, 25th percentile, median, 75th percentile, SD, SEM, mi... | [] |
NCT01192568 | 11.6.5 | Physical Examinations | 11.6.5 Physical Examinations Physical examination assessments will be summarized for each safety population by DB treatment group or oxybutynin chloride gel only group, as applicable, and visit. For each body system and assessment category, the number and percentage of patients will be presented. The denominators for c... | [] |
NCT01192568 | 11.6.6 | Skin Assessments for Erythema | 11.6.6 Skin Assessments for Erythema Skin assessments for erythema will be summarized for each safety population by treatment group and visit for the Pre-Amendment 3 double-blind period and by oxybutynin chloride gel only and visit for the Pre-Amendment 3 open-label period, the Pre-Amendment 3 double-blind and open-lab... | [] |
NCT01192568 | 11.7 | Other Assessments | 11.7 Other Assessments | [] |
NCT01192568 | 11.7.1 | Demographic and Other Pretreatment Characteristics | 11.7.1 Demographic and Other Pretreatment Characteristics Patient demographic and physical characteristic data and medical history data will be summarized for each analysis population using descriptive statistics (mean, 25th percentile, median, 75th percentile, SD, SEM, minimum, maximum, and number of patients) for con... | [] |
NCT01192568 | 11.7.2 | Medications | 11.7.2 Medications Medication usage will be coded using World Health Organization Drug Dictionary Enhanced Anatomical/Therapeutic/Chemical classification. Summaries of medications will be presented for the safety population by anatomical and therapeutic category and preferred name. Pre-Amendment 3, summaries for the do... | [] |
NCT01192568 | 11.7.3 | Compliance | 11.7.3 Compliance Compliance with the study treatment for each patient/visit will be calculated using the following formula: Compliance = $$\left(\frac{\text{# of sachets dispensed} - \text{# returned}}{\text{# expected}}\right) 100$$ The expected number of sachets to be used for each patient will be based on the total... | [] |
NCT01192568 | 11.7.4 | Urodynamic Variables | 11.7.4 Urodynamic Variables Urodynamic variables will be summarized for the Pre-Amendment 3 double-blind and Post-Amendment 3 safety populations. Results will be presented by treatment group and visit and by treatment group, dose level, and visit for the Pre-Amendment 3 double-blind period and by oxybutynin chloride ge... | [] |
NCT01192568 | 11.7.5 | Anticholinergic Symptoms Questionnaire | 11.7.5 Anticholinergic Symptoms Questionnaire Anticholinergic symptom questionnaire data will be summarized for the Pre-Amendment 3 double-blind safety population by treatment group and visit and by treatment group, dose level, and visit for the double-blind period. Anticholinergic symptom questionnaire data will be su... | [] |
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