protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02660138 | 6.3.2 | Detailed Administration Guidance | 6.3.2 Detailed Administration Guidance | 1) | CCI | | |----|-----|--| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | PROTOCOL: FINAL: 16 APRIL 2018 PAGE 70/131  PROTOCOL: FINAL: 16 APRIL 2018 PAGE 71/131  | [] |
NCT02660138 | 6.3.3 | Post-treatment Observation | 6.3.3 Post-treatment Observation Vital signs should be recorded approximately 30 minutes following the procedure. If sedation or general anaesthesia was used then post-treatment observation must also be performed according to local site practice (e.g. monitoring of BP and HR until recovered). For any AEs that occur on ... | [] |
NCT02660138 | 6.4 | Concomitant Medications and Therapies | 6.4 Concomitant Medications and Therapies The following should be recorded in the eCRF: - Any prior or concomitant NDO therapy or medication given to a subject before Screening or during the study - Any prior or concomitant non-NDO therapy or medication given to a subject in the 30 days before Screening or during the s... | [] |
NCT02660138 | 6.4.1 | Permissible Medications and Therapies | 6.4.1 Permissible Medications and Therapies The following concomitant medications are permitted but they must be monitored closely and the dose and dose regimen should preferable remain constant throughout the study: - Oral medication for NDO (e.g. anticholinergics and beta-3 agonists): - must be stable for 4 weeks pri... | [] |
NCT02660138 | 6.4.1.1 | Clean Intermittent Catheterisation | 6.4.1.1 Clean Intermittent Catheterisation All subjects in this study have significant bladder dysfunction and voiding difficulty, requiring routine CIC usage to adequately and regularly drain urine from the bladder. At Screening, subjects must be routinely performing CIC to manage their bladder function, and ensure re... | [] |
NCT02660138 | 6.4.1.2 | Antibiotic Prophylaxis | 6.4.1.2 Antibiotic Prophylaxis Antibiotic prophylaxis is required in the study to cover: - (a) All urodynamic procedures: - CCI - (b) All IMP cystoscopic treatment administration procedures: - CCI The minimum duration of the antibiotics can be lengthened per clinical judgment of the investigator. Antibiotics may be: - ... | [
"Permitted Antibiotics"
] |
NCT02660138 | 6.4.1.3 | Antibiotics for Symptomatic UTI | 6.4.1.3 Antibiotics for Symptomatic UTI Subjects with NDO may demonstrate atypical symptoms for UTI. If there is any suspicion of a UTI then the subject should be immediately commenced on appropriate antibiotics:  | [] |
NCT02660138 | 6.4.2 | Prohibited Medications/Therapies | 6.4.2 Prohibited Medications/Therapies Prohibited throughout the study: - Treatment at any anatomical location with any BTX (with the exception of IMP treatments and retreatments as part of this study) - Medications that affect neuromuscular transmission, such as curare-like depolarising agents, lincosamides, polymyxin... | [
"PROTOCOL: FINAL: 16 APRIL 2018 PAGE 78/131"
] |
NCT02660138 | 6.4.2.1 | Concomitant treatment for Neurogenic Detrusor Overactivity | 6.4.2.1 Concomitant treatment for Neurogenic Detrusor Overactivity These data are to be collected at Screening and at other timepoints. In particular, the following should be collected: - Daily CIC frequency (at Screening, and if there is a clinically significant change in frequency postbaseline) - Current anticholiner... | [] |
NCT02660138 | 7 | ASSESSMENT OF EFFICACY | 7 ASSESSMENT OF EFFICACY For the timing of assessments in this study, refer to the schedules in [Table](#page-47-0) 4, [Table](#page-49-0) 5, and [Table](#page-78-3) 19. | [] |
NCT02660138 | 7.1 | Primary Efficacy Endpoint and Evaluations | 7.1 Primary Efficacy Endpoint and Evaluations See Section [3.2.1.](#page-36-1) | [] |
NCT02660138 | 7.2 | Secondary Efficacy Endpoints and Evaluations | 7.2 Secondary Efficacy Endpoints and Evaluations See Section [3.2.2](#page-36-2) and [Table](#page-78-3) 19. Table 19 Efficacy Endpoints During Initial Treatment and Retreatment | Measure | Planned timepoints(dependent ontiming ofretreatments) | Variable | Endpoint | |---------------------------------------------------... | [
"PROTOCOL: FINAL: 16 APRIL 2018 PAGE 80/131"
] |
NCT02660138 | 7.3 | Methods and Timing of Assessing, Recording, and Analysing Efficacy Data | 7.3 Methods and Timing of Assessing, Recording, and Analysing Efficacy Data Methods for assessing efficacy data are described below. Timing of efficacy assessments are discussed in Section [0.](#page-46-0) Procedures for recording efficacy data are discussed in Section [13.1,](#page-105-1) and methods of analysis are d... | [] |
NCT02660138 | 7.3.1 | Bladder Diary | 7.3.1 Bladder Diary A 7-day bladder diary will be completed by subjects (with the caregiver's assistance if necessary) at Screening and regularly throughout the study to record the following parameters: - Weekly number of UI episodes - Daily urinary frequency (total, spontaneous void only, CIC only) - 24-hour voided vo... | [] |
NCT02660138 | 7.3.2 | Urodynamic Examination | 7.3.2 Urodynamic Examination All subjects will have a standardised urodynamic (filling cystometry) assessment at Screening and again at Week 6 following the first IMP administration. Urodynamics will be conducted according to International Continence Society recommendations [\[20\]](#page-110-4). Full details of the ur... | [] |
NCT02660138 | 7.3.3 | Patient Reported Questionnaires | 7.3.3 Patient Reported Questionnaires In order to ensure accurate and unbiased subject questionnaire completion the following guidelines should be adhered to: - The mPGI-I should be completed by the subject (with the caregiver's assistance, if necessary) prior to the visit (expected to be performed at the beginning of ... | [] |
NCT02660138 | 7.3.3.1 | Incontinence Quality of Life | 7.3.3.1 Incontinence Quality of Life The I-QoL is a highly used, widely recommended, validated, disease-specific questionnaire designed to measure the effect of UI on subjects' QoL [[21,](#page-110-5) [22,](#page-110-6) [23,](#page-110-7) [24\]](#page-110-8). It contains 22 items covering three domains of QoL: - Avoida... | [] |
NCT02660138 | 7.3.3.2 | EuroQol 5-dimension 5-level | 7.3.3.2 EuroQol 5-dimension 5-level The EQ-5D-5L is a widely used non-disease-specific, validated instrument developed by the EuroQol Group (Rotterdam, The Netherlands, www.euroqol.org) to assess health status. It consists of five dimensions covering: - Mobility - Self-care - Usual activities - Pain/discomfort - Anxiet... | [] |
NCT02660138 | 7.3.3.3 | Modified Patient Global Impression of Improvement | 7.3.3.3 Modified Patient Global Impression of Improvement The subject's global impression of treatment response will be assessed using the mPGI-I scale. The mPGI-I will be completed on the electronic device used for the bladder diary. It should be completed before the visit, but may be completed at the beginning of the... | [] |
NCT02660138 | 8 | ASSESSMENT OF SAFETY | 8 ASSESSMENT OF SAFETY | [] |
NCT02660138 | 8.1 | Adverse Events | 8.1 Adverse Events AEs will be monitored from the time that the subject gives informed consent and throughout the study (see Section [3.4](#page-39-2) for a definition of the study duration) and will be elicited by direct, nonleading questioning, or as volunteered by a subject. Further details for AE reporting can be f... | [] |
NCT02660138 | 8.1.1 | Definition of an Adverse Event | 8.1.1 Definition of an Adverse Event An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms... | [] |
NCT02660138 | 8.1.2 | Categorisation of Adverse Events | 8.1.2 Categorisation of Adverse Events | [] |
NCT02660138 | 8.1.2.1 | Intensity Classification | 8.1.2.1 Intensity Classification AEs will be classified as mild, moderate or severe according to the following criteria: - Mild: symptoms do not alter the subject's normal functioning - Moderate: symptoms produce some degree of impairment to function, but are not hazardous, uncomfortable or embarrassing to the subject ... | [] |
NCT02660138 | 8.1.2.2 | Causality Classification | 8.1.2.2 Causality Classification The relationship of an AE to IMP administration will be classified according to the following: - Related: reports including good reasons and sufficient information (e.g. plausible time sequence, dose response relationship, pharmacology, positive dechallenge and/or rechallenge) to assume... | [] |
NCT02660138 | 8.1.2.3 | Assessment of Expectedness | 8.1.2.3 Assessment of Expectedness The reference document for assessing expectedness of AEs/events in this study will be the current Dysport® IB. | [] |
NCT02660138 | 8.1.2.4 | Laboratory Test Abnormalities | 8.1.2.4 Laboratory Test Abnormalities Abnormalities in laboratory test values should only be reported as AEs if any of the following apply: - They result in a change in IMP schedule of administration (change in dose, delay in administration, IMP discontinuation) - They require intervention or a diagnostic evaluation to... | [] |
NCT02660138 | 8.1.2.11 | Adverse Events of Special Interest | 8.1.2.11 Adverse Events of Special Interest The effects of Dysport® and all BTX products may spread from the area of injection to produce symptoms consistent with BTX effects. These symptoms have been reported hours to weeks after injection. Remote spread of toxin that affects swallowing and breathing can be life threa... | [] |
NCT02660138 | 8.1.3 | Recording and Follow-up of Adverse Events | 8.1.3 Recording and Follow-up of Adverse Events At each visit, the subject should be asked a nonleading question such as: "How have you felt since starting the new treatment/the last assessment?" All observed or volunteered AEs, regardless of treatment group or suspected causal relationship to IMP, will be recorded on ... | [] |
NCT02660138 | 8.1.4 | Reporting of Serious Adverse Events | 8.1.4 Reporting of Serious Adverse Events All SAEs (as defined below) regardless of treatment group or suspected relationship to IMP must be reported immediately (within 24 hours of the investigator's knowledge of the event) to the pharmacovigilance contact specified at the beginning of this protocol. If the immediate ... | [] |
NCT02660138 | 8.1.5 | Pregnancy | 8.1.5 Pregnancy Pregnancy itself is not regarded as an AE unless there is a suspicion that the IMP may have interfered with the effectiveness of a contraceptive method. The outcome of any pregnancy will then need to be collected even if this occurs after the end of the study. Information regarding pregnancies must be c... | [] |
NCT02660138 | 8.1.6 | Deaths | 8.1.6 Deaths All AEs resulting in death either during the study period or within 12 weeks (84 days) after the last dose of IMP, must be reported as an SAE within 24 hours of the investigator's knowledge of the event. The convention for recording death is as follows: - AE term: lead cause of death (e.g. multiple organ f... | [] |
NCT02660138 | 8.1.7 | Discontinuation/Withdrawal due to Adverse Events/Serious Adverse Events | 8.1.7 Discontinuation/Withdrawal due to Adverse Events/Serious Adverse Events Discontinuation/withdrawal due to AEs should be distinguished from discontinuation/withdrawal due to insufficient response to the IMP (see Section [4.4\)](#page-45-1). Every effort should be made to try to attribute withdrawal to a single epi... | [] |
NCT02660138 | 8.1.8 | Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators | 8.1.8 Reporting to Competent Authorities/ Independent Ethics Committees/ Institutional Review Boards/ Other Investigators The sponsor or sponsor's representative will ensure that processes are in place for submission of reports of Suspected Unexpected Serious Adverse Reactions occurring during the study to the CAs, Ind... | [] |
NCT02660138 | 8.2 | Clinical Laboratory Tests | 8.2 Clinical Laboratory Tests Blood and urine samples will be collected as indicated in the schedule of assessments in [Table](#page-47-0) 4 and [Table](#page-49-0) 5, for the evaluation of haematology, serum chemistry, laboratory urinalysis/microscopy, urine culture and sensitivity, and anti BTX-A antibodies. Analysis... | [] |
NCT02660138 | 8.2.1 | Haematology | 8.2.1 Haematology Blood samples (approximately 3.0 mL) will be collected in a potassium ethylenediaminetetraacetic acid tube to assess the following parameters: - Red blood cell count - Haemoglobin - Haematocrit - Mean corpuscular volume - Mean corpuscular haemoglobin - Mean corpuscular haemoglobin concentration PROTOC... | [] |
NCT02660138 | 8.2.2 | Serum Chemistry | 8.2.2 Serum Chemistry Blood samples (approximately 4.0 mL) will be collected in an activator gel tube to assess the following parameters: - Urea, creatinine, total bilirubin, conjugated bilirubin - Chloride, bicarbonate, sodium, potassium, calcium, inorganic phosphate - Alkaline phosphatase, aspartate aminotransferase,... | [
"At Screening:"
] |
NCT02660138 | 8.2.3 | Laboratory urinalysis/microscopy | 8.2.3 Laboratory urinalysis/microscopy Fresh urine samples (at least 10 mL) will be collected to assess the following parameters: pH, protein, ketones, bilirubin, blood, urobilinogen, nitrites, leukocytes, glucose and specific gravity. Microscopy will be performed, if indicated, but results will not be collected in the... | [
"Screening",
"During follow-up",
"Discretionary dipstick urinalysis"
] |
NCT02660138 | 8.2.4 | Urine Culture and Sensitivity | 8.2.4 Urine Culture and Sensitivity Fresh urine samples (at least 10 mL) for culture and sensitivity will be collected prior to invasive study procedures to: - Assist in adapted antibiotic prophylaxis selection (see Section [6.4.1.2\)](#page-72-0) for the procedure; or - If empiric antibiotics are used to cover the pro... | [] |
NCT02660138 | 8.2.5 | Pregnancy Test | 8.2.5 Pregnancy Test A urine sample will be collected for a human chorionic gonadotropin pregnancy test as per the schedule in [Table](#page-47-0) 4 and [Table](#page-49-0) 5, for all female subjects of childbearing potential. If this is found to be positive, it will be followed-up with a serum pregnancy test (β-human ... | [] |
NCT02660138 | 8.2.6 | Antibody Testing | 8.2.6 Antibody Testing Blood samples (2 × 6 mL samples) will be collected and serum samples will be sent to the central laboratory for subsequent antibody testing per the schedule in [Table](#page-47-0) 4 and [Table](#page-49-0) 5 for the assay of putative antitoxin-A antibodies. Batch shipping to specific laboratories... | [] |
NCT02660138 | 8.2.7 | Other Laboratory Safety Tests | 8.2.7 Other Laboratory Safety Tests Other laboratory safety tests may be performed at the discretion of the investigator to ensure the safety of the subjects. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 94/131 | [] |
NCT02660138 | 8.2.8 | Blood Volume to be Collected During the Study | 8.2.8 Blood Volume to be Collected During the Study The blood volume collected during the 24-month course of the study depends on the number of treatment cycles received. Assuming 3 mL of blood sampled for each haematology test, 4 mL of blood sampled for each biochemistry test (for serum chemistry), and 12 mL of blood ... | [] |
NCT02660138 | 8.3 | Physical Examination | 8.3 Physical Examination Symptom-driven physical examinations will be conducted per the schedule in [Table](#page-47-0) 4 and [Table](#page-49-0) 5, and may also be performed at any other time during the study if clinically indicated. The first physical examination is conducted at Screening Visit 1. Accordingly, any ph... | [] |
NCT02660138 | 8.4 | Vital Signs | 8.4 Vital Signs Vital signs consist of HR, respiratory rate, BP and body temperature: - HR, respiratory rate and BP should be measured in the sitting or supine position, but must be performed consistently throughout the study - Body temperature should be measured using a consistent method throughout the study (oral or ... | [
"Screening Visit 1",
"Treatment and Retreatment Visits"
] |
NCT02660138 | 9 | STATISTICS | 9 STATISTICS | [] |
NCT02660138 | 9.1 | Analysis Populations | 9.1 Analysis Populations The following populations will be used during statistical analyses: - Screened population: All subjects screened (i.e. who signed the informed consent) - Safety population: All subjects who received at least one IMP administration (including only partial administration) of the IMP. Subjects wil... | [] |
NCT02660138 | 9.1.1 | Populations Analysed | 9.1.1 Populations Analysed The primary analysis based on the primary efficacy endpoint will be performed on the mITT population. In addition, a supportive analysis will be conducted on the PP population. The analyses of safety data will be performed based on the safety population. | [] |
NCT02660138 | 9.1.2 | Subject Allocation and Reasons for Exclusion from the Analyses | 9.1.2 Subject Allocation and Reasons for Exclusion from the Analyses Any major protocol deviation (see Section [11.1.2](#page-101-3) for definition) will be described in the Protocol Deviation Document and its impact on inclusion in each analysis population (mITT, PP and safety populations) for any subject will be spec... | [] |
NCT02660138 | 9.2 | Sample Size Determination | 9.2 Sample Size Determination The sample size is based on the ability to detect a statistically significant treatment difference in the weekly number of UI episodes at Week 6 following treatment in the two Dysport® arms compared to the placebo arm. Assuming a decrease of 21 UI episodes per week in each Dysport® arm and... | [] |
NCT02660138 | 9.3 | Significance Testing and Estimations | 9.3 Significance Testing and Estimations All statistical tests will be performed two-sided with a type one error rate set at 5%. Experiment-wise control of type one error for the primary endpoint will be performed using a conservative approach. The primary efficacy hypotheses are as follows: - 1) Ho: There is no differ... | [] |
NCT02660138 | 9.4 | Statistical/Analytical Methods | 9.4 Statistical/Analytical Methods Statistical analyses will be performed by an external CRO, managed by the sponsor's Biometry Department. A SAP describing the planned statistical analysis in detail will be developed as a separate document. Statistical evaluation will be performed using Statistical Analysis System® (v... | [] |
NCT02660138 | 9.4.1 | Demographic and Other Baseline Characteristics | 9.4.1 Demographic and Other Baseline Characteristics In order to ensure balance of treatment groups, descriptive summary statistics (number of patients, mean, standard deviation, standard error mean, 95% confidence interval, median, minimum, maximum) or frequency counts of demographic and baseline data (medical history... | [] |
NCT02660138 | 9.4.2 | Homogeneity of Treatment Groups | 9.4.2 Homogeneity of Treatment Groups In order to assess the homogeneity of treatment groups at Baseline, 95% confidence intervals will be provided to detect any clinical nonhomogeneity. | [] |
NCT02660138 | 9.4.3 | Data Imputation | 9.4.3 Data Imputation No imputation is planned for the primary analysis of the primary endpoint. For sensitivity analyses, imputation will be performed using a multiple imputation approach for handling missing data on the mITT population. | [] |
NCT02660138 | 9.4.4 | Subject Disposition and Withdrawals | 9.4.4 Subject Disposition and Withdrawals The numbers and percentages of subjects enrolled and included in the analysis populations mentioned in Section [9.1.1](#page-94-2) will be tabulated by country and site. The reasons for subject exclusions from each of the populations will also be tabulated. In addition, the num... | [] |
NCT02660138 | 9.4.5 | Efficacy Evaluation | 9.4.5 Efficacy Evaluation As indicated in Section [7.1,](#page-78-1) the primary efficacy variable is the change in the weekly number of UI episodes from Baseline (Day 1) to Week 6 after the first treatment. Secondary efficacy variables are: - weekly number of UI episodes - MCC - MDP during storage - Vol@1stIDC - propo... | [] |
NCT02660138 | 9.4.6 | Adjustment for Country/Site Effect | 9.4.6 Adjustment for Country/Site Effect No stratification for country/site is to be performed, and no adjustment for country or site effect is planned. | [] |
NCT02660138 | 9.4.7 | Safety Evaluation | 9.4.7 Safety Evaluation All safety data will be included in the subject data listings. Analyses and summary tables will be based upon the safety population. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) (current version at the time of database lock), and will be classified... | [] |
NCT02660138 | 9.4.8 | Antibody Testing | 9.4.8 Antibody Testing The number and percentage of subjects with the presence of neutralising BTX-A antibodies at Baseline will be described. The number of seroconverters (subjects having a negative result at Baseline and at least one positive result at one post-treatment timepoint) for neutralising antibodies will be... | [] |
NCT02660138 | 9.5 | Subgroup Analyses | 9.5 Subgroup Analyses Descriptive statistics for the primary and selected secondary endpoints (to be defined in the SAP) will be provided for the mITT population within each category of the randomisation stratification variables: aetiology of NDO (SCI or MS) and also BTX-A bladder naive and PROTOCOL: FINAL: 16 APRIL 20... | [] |
NCT02660138 | 10 | DIRECT ACCESS TO SOURCE DATA AND DOCUMENTS | 10 DIRECT ACCESS TO SOURCE DATA AND DOCUMENTS Authorised personnel from external CAs and sponsor authorised Quality Assurance personnel may carry out inspections and audits. The purpose of an audit is to ensure that ethical, regulatory and quality requirements are fulfilled in all studies performed by the sponsor. Audi... | [] |
NCT02660138 | 11 | QUALITY CONTROL AND QUALITY ASSURANCE | 11 QUALITY CONTROL AND QUALITY ASSURANCE | [] |
NCT02660138 | 11.1 | Protocol Amendments and Protocol Deviations | 11.1 Protocol Amendments and Protocol Deviations | [] |
NCT02660138 | 11.1.1 | Protocol Amendments | 11.1.1 Protocol Amendments No changes from the final approved (signed) protocol will be initiated without the prior written approval or favourable opinion of a written amendment by the IEC/IRB, except when necessary to eliminate immediate safety concerns to the subjects or when the change involves only logistics or adm... | [] |
NCT02660138 | 11.1.2 | Protocol Deviations and Exceptions | 11.1.2 Protocol Deviations and Exceptions All protocol deviations will be identified and recorded by the sponsor or sponsor's representative (see Sections [11.3,](#page-101-5) [11.4,](#page-102-0) and [11.5\)](#page-102-1). A major protocol deviation is any significant divergence from the protocol, i.e. nonadherence on... | [] |
NCT02660138 | 11.2 | Information to Study Personnel | 11.2 Information to Study Personnel The investigator is responsible for giving information about the study to all staff members involved in the study or in any element of subject management, both before starting any study procedures and during the course of the study (e.g. when new staff become involved). The investiga... | [] |
NCT02660138 | 11.3 | Study Monitoring | 11.3 Study Monitoring The investigator is responsible for the validity of all data collected at the site. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 103/131 The sponsor or sponsor's representative is responsible for monitoring these data to verify that the rights and wellbeing of subjects are protected, that study data are ac... | [] |
NCT02660138 | 11.4 | Audit and Inspection | 11.4 Audit and Inspection Authorised personnel from external CAs and the sponsor's authorised Quality Assurance personnel may carry out inspections and audits (see Section [10\)](#page-100-0). | [] |
NCT02660138 | 11.5 | Data Quality Assurance | 11.5 Data Quality Assurance Monitored eCRFs transferred electronically from the investigational site to the assigned Data Management group at the CRO will be reviewed (secondary monitoring) for completeness, accuracy, consistency, and protocol compliance. Reasons should be given on the relevant eCRF for any missing dat... | [] |
NCT02660138 | 12 | ETHICS | 12 ETHICS | [] |
NCT02660138 | 12.1 | Compliance with Good Clinical Practice and Ethical Considerations | 12.1 Compliance with Good Clinical Practice and Ethical Considerations This study will be conducted in compliance with IECs/IRBs, informed consent regulations, all applicable local regulations, the Declaration of Helsinki and ICH GCP Guidelines (Section 1 or 1.6). In addition, this study will adhere to FDA, 21 CFR Part... | [] |
NCT02660138 | 12.2 | Informed Consent | 12.2 Informed Consent Prior to study entry, the investigator, or a person designated by the investigator, will explain the nature, purpose, benefits and risks of participation in the study to each subject or subject's legally acceptable representative. Written informed consent must be obtained prior to the subject ente... | [] |
NCT02660138 | 12.3 | Health Authorities and Independent Ethics Committees/Institutional Review Boards | 12.3 Health Authorities and Independent Ethics Committees/Institutional Review Boards As required by local regulations, the sponsor's or sponsor's representative's Regulatory Affairs group will ensure all legal regulatory aspects are covered, and obtain approval of the appropriate regulatory bodies, prior to study init... | [] |
NCT02660138 | 12.4 | Confidentiality Regarding Study Subjects | 12.4 Confidentiality Regarding Study Subjects The investigator must assure that the privacy of the subjects, including their personal identity and all personal medical information, will be maintained at all times. In eCRFs and other documents or image material submitted to the sponsor, subjects will be identified by a ... | [] |
NCT02660138 | 13 | DATA HANDLING AND RECORD KEEPING | 13 DATA HANDLING AND RECORD KEEPING | [] |
NCT02660138 | 13.1 | Data Recording of Study Data | 13.1 Data Recording of Study Data In compliance with GCP, the medical records/medical notes, etc., should be clearly marked and permit easy identification of a subject's participation in the specified clinical study. The investigator must record all data relating to protocol procedures, IMP administration, laboratory d... | [] |
NCT02660138 | 13.2 | Data Management | 13.2 Data Management EDC will be utilised for collecting subject data. Each site is required to have a computer and internet connection available for site entry of clinical data. All entries in the eCRF will be done under the electronic signature of the person performing the action. This electronic signature consists o... | [] |
NCT02660138 | 13.3 | Record Archiving and Retention | 13.3 Record Archiving and Retention During the prestudy and initiation visits, the monitor must ensure the archiving facilities are adequate and archiving/retention responsibilities of the investigator have been discussed. Study documents should be retained until at least 2 years after the last approval of a marketing ... | [] |
NCT02660138 | 14 | FINANCING AND INSURANCE | 14 FINANCING AND INSURANCE | [] |
NCT02660138 | 14.1 | Contractual and Financial Details | 14.1 Contractual and Financial Details The investigator (and/or, as appropriate, the hospital administrative representative) and the sponsor's representative will sign a clinical study agreement prior to the start of the study, outlining overall sponsor and investigator responsibilities in relation to the study. Financ... | [] |
NCT02660138 | 14.2 | Insurance, Indemnity and Compensation | 14.2 Insurance, Indemnity and Compensation The sponsor will provide Product Liability insurance for all subjects included in the clinical study. Where required, a hospital specific indemnity agreement will be used. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 109/131 | [] |
NCT02660138 | 15 | REPORTING AND PUBLICATIONS OF RESULTS | 15 REPORTING AND PUBLICATIONS OF RESULTS | [] |
NCT02660138 | 15.1 | Publication Policy | 15.1 Publication Policy The sponsor encourages acknowledgement of all individuals/organisations involved in the funding or conduct of the study, including medical writers or statisticians, subject to the consent of each individual and entity concerned, including acknowledgement of the sponsor. The results of this study... | [] |
NCT02660138 | 15.2 | Clinical Study Report | 15.2 Clinical Study Report In order to support regulatory submission an ICH E3-compliant clinical study report (CSR) may be prepared prior to completion of the study. See Section [9.6](#page-99-0) for details regarding this primary analysis. A final CSR will be prepared according to the ICH guideline on structure and c... | [] |
NCT02660138 | 16 | REFERENCES | 16 REFERENCES - 1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 2003;61(1):37-49. - 2. Haab F. Chapter 1: The conditions of neurogenic detrusor overactivity and overa... | [] |
NCT02667457 | 1 | St u d y S y n o p si s | 1. St u d y S y n o p si s | I n v e sti g ati o n alM e di ci n alPr o d u ct | Kit f or t h e Pr e p ar ati o n ofT c R e c o m bi n a nt H u m a n A n n e xi n V- 1 2 8 f or9 9 mI nj e cti o n | |--------------------------------------------------------------|----------------------------------------------------------... | [
"Primary endpoint of PoC:",
"Primary endpoint of Phase II:",
"Secondary endpoints:",
"Safety:",
"Table 1 – Visit Schedule"
] |
NCT02667457 | 2 | List of abbreviations | 2. List of abbreviations AE Adverse Event BUN Blood Urea Nitrogen e-CRF CRO Electronic Case Report Form Clinical Research Organization CRP C-Reactive Protein CT Computed Tomography DMC Data Monitoring Committee ELISA Enzyme-Linked Immuno-absorbent Assay ESR FDA Erythrocyte Sedimentation Rate Food and Drug Administratio... | [] |
NCT02667457 | 3 | Background and Rationale | 3. Background and Rationale Atherosclerosis is projected to become an internationally leading cause of mortality1-3and is the underlying pathophysiology responsible for angina, myocardial infarction, transient ischemic attacks and stroke. Atherosclerosis is an inflammatory disease process that begins with the formation... | [] |
NCT02667457 | 4 | St u d y O bj e cti v e s | 4. St u d y O bj e cti v e s T h e pri m ar y o bj e cti v e of t hi s i n v e sti g ati o n i s: • T o d et er mi n e t h e f e a si bilit y of i m a gi n g a p o pt oti c a cti vit y i n c ar oti d at h er o s cl er oti c pl a q u e s of a s y m pt o m ati c or pr e vi o u s s y m pt o m ati c wit h TI A o nl y p ati... | [] |
NCT02667457 | 5 | H y p ot h e s e s | 5. H y p ot h e s e s | [] |
NCT02667457 | 5 | 1 Pri m ar y H y p ot h e si s | 5. 1 Pri m ar y H y p ot h e si s 9 9 m T c-r h A n n e xi n V- 1 2 8 i m a gi n g c a n b e u s e d t o d et e ct a p o pt o si s i n c ar oti d pl a q u e i n a s y m pt o m ati c or pr e vi o u sl y s y m pt o m ati c wit h TI A o nl y p ati e nt s wit h at l e a st 5 0 % c ar oti d st e n o si s a s d efi n e d b y... | [] |
NCT02667457 | 5 | 2 S e c o n d ar y H y p ot h e s e s | 5. 2 S e c o n d ar y H y p ot h e s e s - 9 9 m T c-r h A n n e xi n V- 1 2 8 u pt a k e will b e i n cr e a s e d i n pl a q u e wit h gr e at er e c h o g e ni cit y - 9 9 m T c-r h A n n e xi n V- 1 2 8 u pt a k e will b e d e cr e a s e d i n pl a q u e wit h gr e at er e c h ol u c e n c y - 9 9 m T c-r h A n n e... | [] |
NCT02667457 | 6 | St u d y D e si g n | 6. St u d y D e si g n T hi s i s a si n gl e- c e ntr e, si n gl e d o s e, Pr o of of C o n c e pt ( P o C), P h a s e II st u d y. P arti ci p a nt s will r e c ei v e a si n gl e i ntr a v e n o u s b ol u s of 3 5 0 M B q ± 1 0 % of 9 9 m T c-r h A n n e xi n V- 1 2 8 f oll o w e d b y pl a n ar a n d S P E C T/ C... | [] |
NCT02667457 | 7 | E n d of St u d y | 7. E n d of St u d y T h e e n d of t h e st u d y i s d efi n e d a s t h e c o m pl eti o n of all st u d y pr o c e d ur e s o n t h e l a st e nr oll e d p arti ci p a nt (i. e. l a st vi sit l a st p arti ci p a nt). | [] |
NCT02667457 | 8 | St u d y P o p ul ati o n | 8. St u d y P o p ul ati o n A p pr o v al f or t h e st u d y will b e o bt ai n e d fr o m t h e Ott a w a H o s pit al S ci e n c e N et w or k R e s e ar c h Et hi c s B o ar d ( O H S N- R E B) a n d H e alt h C a n a d a. All p arti ci p a nt s will pr o vi d e writt e n i nf or m e d c o n s e nt pri or t o t h ... | [] |
NCT02667457 | 8 | 1 I n cl u si o n crit eri a | 8. 1 I n cl u si o n crit eri a F or all p arti ci p a nt s: | AAA-Annexin-04 | | Page 17 of 45 | | |----------------|--|---------------|--| | Study Protocol | | | | - 1. Males and females age 18 years or greater; - 2. Able and willing to comply with the study procedures; - 3. Negative pregnancy test for women of child... | [
"For control participants:"
] |
NCT02667457 | 8.2 | Exclusion criteria | 8.2 Exclusion criteria - 1. Previous carotid stenting or endarterectomy, or stroke; - 2. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans); - 3. Pregnancy or lactation; - 4. History of any disease or relevant physical or psychiatric condition or abnormal physical findi... | [] |
NCT02667457 | 8.3 | Source of Study Population | 8.3 Source of Study Population The carotid artery study population will be adult male and female patients who are referred to the outpatient cardiology clinics and/or the non-invasive Diagnostic Imaging Department at the University of Ottawa Heart Institute. The control population will be healthy volunteers who do not ... | [] |
NCT02667457 | 8.4 | Participants Study Identification | 8.4 Participants Study Identification Each participant will be identified with a participant ID number. A unique participant identification number (Participant ID) will be assigned at the start of the screening period to each participant who signs the informed consent form. This number will identify the participant thr... | [] |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.