protocol_id stringclasses 263
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NCT03679767 | 8.3.4 | ECOG Performance Status | 8.3.4. ECOG Performance Status ECOG performance status will be assessed according to the criteria in [Table 11.](#page-42-3) Table 11: ECOG Performance Status | Grade | Performance Status | |-------|-------------------------------------------------------------------------------------------------------------------------... | [] |
NCT03679767 | 8.3.5 | Electrocardiograms | 8.3.5. Electrocardiograms Electrocardiograms will be obtained as outlined in [Table 3](#page-13-0) according to the institutional standard of care. A 12-lead machine that automatically calculates heart rate and measures PR, QRS, QT, and QTc intervals is recommended. All ECGs should be performed with the participant in ... | [] |
NCT03679767 | 8.3.6 | Laboratory Assessments | 8.3.6. Laboratory Assessments Clinical safety laboratory analyses (ie, blood chemistries, hematology assessments, coagulation tests, endocrine function, lipid panel [fasting], and urinalysis) will be performed in certified local laboratories associated with study sites. Blood and urine samples will be collected for lab... | [] |
NCT03679767 | 8.3.6.1 | Pregnancy Testing | 8.3.6.1. Pregnancy Testing Serum pregnancy tests are required for all women of childbearing potential during screening and either EOT or the safety follow-up visit 28 days after the last dose. Pregnancy testing is required on Day 1 of all cycles and can be either serum- or urine-based and will be performed before admin... | [] |
NCT03679767 | 8.4 | Pharmacokinetic Assessments | 8.4. Pharmacokinetic Assessments Assessment of PK is an important objective of this study, representing the first clinical experience with administration of INCMGA00012 as a 30-minute infusion. Blood samples for PK analysis will be obtained at the visits and timepoints indicated in [Table 4.](#page-15-0) After the prei... | [] |
NCT03679767 | 8.5 | Pharmacodynamic Assessments | 8.5. Pharmacodynamic Assessments | [] |
NCT03679767 | 8.5.1 | Description of Analyses | 8.5.1. Description of Analyses Additional optional specimens may be collected at any time during study to assess changes associated with safety, efficacy, or resistance to treatment. Analyses will be conducted by Incyte Corporation (Wilmington, DE) or Incyte's designee. The collection schedule is found in Table 4. | [] |
NCT03679767 | 8.6 | Unscheduled Visits | 8.6. Unscheduled Visits Unscheduled study visits may occur at any time if medically warranted. Any assessments performed at those visits should be recorded in the eCRF. | [] |
NCT03679767 | 8.7 | End of Treatment and/or Early Termination | 8.7. End of Treatment and/or Early Termination Once a participant permanently discontinues study treatment, the EOT visit should be conducted, and the data should be entered in the EOT visit in the eCRF. If the EOT visit coincides with a regular study visit, the EOT evaluations will supersede those of that scheduled vi... | [] |
NCT03679767 | 8.8 | Follow-Up | 8.8. Follow-Up The study design includes a follow-up period for participants subsequent to the end of the study treatment period. After discontinuation of study treatment, all study participants continue in the follow-up period of the study. | [] |
NCT03679767 | 8.8.1 | Safety Follow-Up | 8.8.1. Safety Follow-Up The safety follow-up period starts once the participant discontinues study treatment. Approximately 28 days after the final dose of study drug (± 7 days), participants are to attend a clinical visit for a safety evaluation. During this visit, blood will be collected for safety laboratory analysi... | [] |
NCT03679767 | 9 | ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING | 9. ADVERSE EVENTS: DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING | [] |
NCT03679767 | 9.1 | Definition of Adverse Event | 9.1. Definition of Adverse Event
Adverse Event Definition - An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. - An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or ... | [
"Adverse Event Definition",
"Events Meeting the Adverse Event Definition",
"Events NOT Meeting the Adverse Event Definition"
] |
NCT03679767 | 9.2 | Definition of Serious Adverse Event | 9.2. Definition of Serious Adverse Event If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due to progression of disease). | [] |
NCT03679767 | A | Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: | A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose:
a. Results in death
b. Is life-threatening The term 'life-threatening' in the definition of 'serious' refers to an adverse drug experience that places the participant, in the opinion of the initial reporter, at immediate risk of ... | [
"a. Results in death",
"b. Is life-threatening",
"c. Requires inpatient hospitalization or prolongation of existing hospitalization",
"d. Results in persistent or significant disability/incapacity",
"e. Is a congenital anomaly/birth defect",
"f. Other situations (Important Medical Event)",
"9.3. Recordi... |
NCT03686397 | 1 | INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE | 1. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE Gall, 30-36 08950 - Esplugues de Llobregat Barcelona — Spain Enrique Jimenez, MD, Medical Director Principal Investigator \ I [ e-mail: ejimenez@svt.com Telephone: N Adverse Event Reporting !Clinical Safety I Clinical Safety and Distribution \ SAE reporting line - EU ... | [] |
NCT03686397 | 2 | INTRODUCTION | 2. INTRODUCTION | [] |
NCT03686397 | 2.1 | Background | 2.1 Background Acute otitis externa, also called "swimmer's ear", is a diffuse inflammation of the external ear canal, which includes the auricle, auditory canal and eardrum (Vennewald et al., 2010). Inflammation can extend to the pinna distally or to the tympanic membrane proximally (Osguthorpe et al., 2006; Schaefer ... | [] |
NCT03686397 | 2.2 | Rationale for the Study | 2.2 Rationale for the Study Clotrimazole is a broad spectrum antifungal agent that was found to effectively controls fungal isolates attributed to otomycosis (Aspergillus and Candida) when administered as 1% otic solution twice daily. Each dose consists of approximately 1.7 mg of clotrimazole. The dosing regimen has be... | [] |
NCT03686397 | 2.3 | Risk-Benefit Assessment | 2.3 Risk-Benefit Assessment Clotrimazole is used worldwide for treating fungal infections, including the fungal otitis externa (otomycosis). However, it is important to note that in US there are no clotrimazole otic products approved for human use and clotrimazole solutions and creams are used off-label for otic delive... | [] |
NCT03686397 | 3 | OBIJECTIVES | 3. OBIJECTIVES | [] |
NCT03686397 | 3.1 | Primary Objective | 3.1 Primary Objective To demonstrate the superior efficacy of Clotrimazole vs. placebo in the treatment of otomycosis, with respect to the therapeutic cure at test-of-cure (TOC; Visit 4) in the MITT population. Therapeutic cure is defined as both mycological cure AND clinical cure. Mycological cure is defined as eradic... | [] |
NCT03686397 | 3.2 | Secondary Objectives | 3.2 Secondary Objectives - e Overall clinical cure at Visits 2, 3 and 4. - e Mycological cure at Visits 2, 3 and 4. - e Therapeutic cure at Visit 2 and 3. - e Changes in TSSS at Visits 2, 3 and 4. - e Changes in individual signs and symptoms at Visits 2, 3 and 4. In the case of bilateral otomycosis the non-selected ear... | [
"4, OVERALL DESIGN AND PLAN OF THE STUDY"
] |
NCT03686397 | 4.1 | Overview | 4.1 Overview This is a randomized, parallel-group, double-blinded, active-controlled, multicenter study comparing Clotrimazole 1% otic solution with Placebo in the treatment of fungal otitis externa (otomycosis) in adults. A diagram of the study design is shown in Figure 1, and the schedule of observations and procedur... | [] |
NCT03686397 | 4.2 | Justification for Study Design | 4.2 Justification for Study Design The study follows US Food and Drug Administration (FDA) recommendations, and is designed to demonstrate the superiority of an otic solution of Clotrimazole 1% against a matching placebo in the topical treatment of otomycosis. Clotrimazole is a broad spectrum antifungal agent that was ... | [] |
NCT03686397 | 5 | STUDY POPULATION | 5. STUDY POPULATION | [] |
NCT03686397 | 5 | 1Inclusion Criteria | 5.1Inclusion Criteria - At least 18 years of age at Visit 1 (Day 1, Screening/Baseline). - il= Clinical diagnosis of fungal otitis externa (otomycosis) in one or both ears, where topical treatment is indicated. - kS Presence of at least two of the following symptoms at baseline: of pruritus, otalgia and ear fullness. -... | [] |
NCT03686397 | 5.2 | Exclusion Criteria | 5.2 Exclusion Criteria - R Known bacterial otitis externa or malignant otitis externa. - Tympanic perforation, tympanostomy tubes inserted or post mastoid surgery. - Structural ear anomalies which may difficult the evaluation of the therapeutic response. - s Uncontrolled diabetes mellitus. - g Known or suspected hypers... | [] |
NCT03686397 | 5.3 | Withdrawal, Premature Discontinuation of Study Medication, and Replacement of Patients | 5.3 Withdrawal, Premature Discontinuation of Study Medication, and Replacement of Patients Patients must be withdrawn from the study if they withdraw consent to participate. Such withdrawal may occur at any time during the study. Patients are not required to state their reasons for withdrawing consent. Patients who do ... | [] |
NCT03686397 | 5.4 | Planned Sample Size and Study Sites | 5.4 Planned Sample Size and Study Sites Planned enroliment is 191 adults. Patients will be randomized in a 2:1 ratio (Clotrimazole 1% otic solution : Placebo), with the aim of including 150 evaluable patients (100 clotrimazole and 50 placebo). About 17 study sites in Europe (5 in Bulgaria, 2 in Portugal, 5 in Romania a... | [] |
NCT03686397 | 5.5 | Patient Identification and Randomization | 5.5 Patient Identification and Randomization Patients will be randomized at Visit 1, after signing informed consent and meeting eligibility criteria. Randomization will be conducted through an Interactive Web Response System (IWRS) include blocking. The IWRS will assign a patient number, which will be used to identify ... | [] |
NCT03686397 | 6 | STUDY MEDICATION | 6. STUDY MEDICATION | [] |
NCT03686397 | 6.1 | Identity | 6.1 Identity
Investigational Medication Chemical name Clotrimazole Generic name Clotrimazole 1% Otic Solution Trade name Not applicable Dosage form Auricular solution, sterile Manufacturer SALVAT Otic solution in single-dose low-density polyethylene (LDPE) translucent vials containing 0.17 mL Description Generic name ... | [
"Investigational Medication",
"Reference Medication"
] |
NCT03686397 | 6.2 | Administration | 6.2 Administration Study medication will be self-administered by the patient. At Visit 1, a study staff member will instruct the patient in how to open the containers and administer study medication, and will supervise the patient during administration of the first dose. The method of administration for the investigati... | [] |
NCT03686397 | 6.3 | Packaging, Labeling, and Storage | 6.3 Packaging, Labeling, and Storage The primary packaging of study medication will be performed by SALVAT, who will supply the investigational medication as pouches of single-dose vials, as described in Section 6.2. SALVAT will send the pouches directly to JJJil]. Each individual vial will contain 0.17 mL deliverable ... | [] |
NCT03686397 | 6.4 | Blinding and Breaking the Blind | 6.4 Blinding and Breaking the Blind All study medication products (test and placebo) will have the same packaging and labels. The boxes in which the study medication is packaged, shipped, and dispensed will be identical in appearance. When patients return their used and unused study medication containers to the study s... | [] |
NCT03686397 | 6.5 | Drug Accountability | 6.5 Drug Accountability (Clotrimazole 1% otic solution) and the placebo (Saline solution 0.9%). The Investigator will confirm receipt of all kits of study medication using the IWRS and will document receipt in the written study files. The Investigator will dispense the study medication only to patients included in this... | [] |
NCT03686397 | 6.6 | Compliance | 6.6 Compliance Compliance will be assessed by a review of the number of vials returned. The number of doses the patient actually took during the treatment period will be divided by the number of doses the patient was expected to take during that period. The resulting ratio will be multiplied by 100% to determine percen... | [] |
NCT03686397 | 6.7 | Concomitant Medications | 6.7 Concomitant Medications Any medication the patient takes other than the study medication specified in the protocol is considered a concomitant medication. This includes prescribed medications, over-the-counter medications, herbal remedies, etc. All concomitant medications must be recorded in the EDC. At Visit 1, pa... | [] |
NCT03686397 | 6.7.1 | Prohibited Concomitant Medications | 6.7.1 Prohibited Concomitant Medications The following medications will be prohibited during the study (unless the subject has prematurely discontinued study treatment): - Any investigational drug. - Any systemic antimicrobial or antifungal drug. - e Any compound, agent or substance that is applied or instilled to the ... | [] |
NCT03686397 | 6.7.2 | Rescue Concomitant Medication | 6.7.2 Rescue Concomitant Medication Prohibited medication will be considered rescue medication if they meet both of the following criteria: - e Any otic or systemic treatment administered for reasons associated with otomycosis of the evaluable ear (Note — topical products applied in the non-evaluable ear are NOT consid... | [] |
NCT03686397 | 6.7.3 | Recommended Concomitant Analgesics | 6.7.3 Recommended Concomitant Analgesics For patients who require analgesic medications for otalgia, the recommended medication is acetaminophen (paracetamol). The use of acetaminophen should never be considered as an initial treatment for otalgia, thus will only be administered after confirming that the study medicati... | [] |
NCT03686397 | 7 | VARIABLES AND METHODS | 7. VARIABLES AND METHODS | [] |
NCT03686397 | 7.1 | Efficacy Parameters | 7.1 Efficacy Parameters | [] |
NCT03686397 | 7.1.1 | Clinical Efficacy Parameters 7.1.1.1 Pruritus | 7.1.1 Clinical Efficacy Parameters 7.1.1.1 Pruritus Pruritus in both ears will be assessed by the investigator at all visits. For consistency, the same individual should perform all the assessments at all visits, if possible. Pruritus will be assessed - e Severe (3) if pruritus is marked or intense - e Moderate (2) if ... | [] |
NCT03686397 | 7.1.1.2 | Otalgia | 7.1.1.2 Otalgia Otalgia in both ears will be assessed at all visits. The investigator will ask the patient to assess his or her level of otalgia on the day of the visit. If the patient has taken analgesic medication, he or she will be asked to assess the level of otalgia before taking the analgesic. For consistency, th... | [] |
NCT03686397 | 7.1.1.3 | Ear fullness | 7.1.1.3 Ear fullness Ear fullness (aural fullness or ear pressure) in both ears will be assessed by the investigator at all visits. For consistency, the same individual should perform all the assessments at all visits, if possible. Ear fullness will be assessed as: Severe (3) if ear fullness, is marked or intense Moder... | [] |
NCT03686397 | 7.1.1.4 | Otorrhea | 7.1.1.4 Otorrhea Otorrhea in both ears will be assessed by the investigator at all visits. For consistency, the same individual should perform all the assessments at all visits, if possible. Otorrhea will be assessed QS: - Severe (3): copious discharge that prevents visualization of the tympanic membrane unless the flu... | [] |
NCT03686397 | 7.1.1.5 | Overall Clinical Outcome | 7.1.1.5 Overall Clinical Outcome Overall Clinical Outcome is based on the TSSS, which is calculated by the sum of pruritus score + otalgia score + ear fullness score + otorrhea score. Patients will be allocated to one of the following categories for Overall Clinical Outcome: - 1. Clinical Cure: TSSS is 0, as defined in... | [] |
NCT03686397 | 7.1.2.1 | Mycological Outcome | 7.1.2.1 Mycological Outcome Samples of ear discharge will be taken at V1, and in addition at visits V2, V3 and V4, when discharge is present. The otorrhea/debris sample will be taken prior to the debridement of the affected ear. A central laboratory will provide exudate sampling kits with standardized instructions for ... | [] |
NCT03686397 | 7.1.3 | Therapeutic response | 7.1.3 Therapeutic response The therapeutic response is a combined assessment of the Overall Clinical Outcome plus the Mycological Outcome. The following categories are defined: - 1. Therapeutic cure: TSSS (pruritus + otalgia + ear fullness + otorrhea) =0 and mycological outcome eradication or presumed eradication. - 2.... | [] |
NCT03686397 | 7.1.4 | Primary Efficacy Endpoint | 7.1.4 Primary Efficacy Endpoint Based on the definitions in Section 7.1.1.5 7.1.2 and 7.1.3, the primary efficacy endpoint will be the proportion of patients with Therapeutic cure at Test of Cure (Visit 4) in the mycological intended- to-treat (MITT) population. Version 2.0 A#1; 31 October 2019 36 of 63 Confidential , ... | [] |
NCT03686397 | 7.1.5 | Secondary Efficacy Endpoints | 7.1.5 Secondary Efficacy Endpoints Based on the definitions in Sections 7.1.1, 7.1.2 and 7.1.3, the secondary efficacy endpoints will be: e Overall clinical cure at Visits 2, 3 and 4. - Mycological cure at Visits 2, 3 and 4. - Therapeutic cure at Visit 2 and 3. - e Changes in TSSS at Visits 2, 3 and 4. - e Changes in i... | [] |
NCT03686397 | 7.2 | Safety Parameters | 7.2 Safety Parameters Safety will be assessed by AEs and physical examination. In addition, a urine pregnancy test for females of childbearing potential will be performed at Visit 1. Adverse events will be recorded throughout the study and at early termination, and will be coded using the Medical Dictionary for Regulat... | [] |
NCT03686397 | 7.2.1.4.1 | Serious Adverse Event | 7.2.1.4.1 Serious Adverse Event International Conference on Harmonization (ICH) Guidelines and federal regulations define a SAE as any untoward medical occurrence that at any dose results in any of the following outcomes: e death; - e life-threatening. This means that the patient is at risk of death at the time of the ... | [] |
NCT03686397 | 7.2.1.4.2 | Severity | 7.2.1.4.2 Severity The severity of each AE must be assessed by the Investigator and recorded on the Adverse Events EDC as mild, moderate, or severe according to the following definitions: - e Mild: An AE that does not interfere with usual activities; - e Moderate: An AE that interferes with usual activities; or - e Sev... | [] |
NCT03686397 | 7.2.1.4.3 | Relationship to Study Medication | 7.2.1.4.3 Relationship to Study Medication The relationship of each AE to study medication must be assessed and recorded on the Adverse Events EDC as one of the following: - Not related: an AE which is not related to the use of the study medication. - Possibly related: an AE for which an alternative explanation is more... | [] |
NCT03686397 | 7.2.1.5.1 | Initial Reports | 7.2.1.5.1 Initial Reports All SAEs occurring from the time of informed consent until 30 days following the final dose of study drug must be reported to |IIJEl Clinical Safety no later than 24 hours of the knowledge of the occurrence, regardless of relationship to study medication. To report the SAE, investigators have ... | [] |
NCT03686397 | 7.2.1.5.2 | Follow-Up Reports | 7.2.1.5.2 Follow-Up Reports The Investigator must continue to follow the patient until the SAE has subsided or until the condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the patient dies. This follow-up may extend after the end of the study. Version 2.0 A#1; 31 October 2019 40 ... | [] |
NCT03686397 | 7.2.1.6 | Reporting Safety Information | 7.2.1.6 Reporting Safety Information The Sponsor or Sponsor's designee will report all relevant information about suspected unexpected serious adverse reactions that are fatal or life-threatening as soon as possible to regulatory authoritiesand in any case no later than 7 days after Sponsor or Sponsor's designee knowle... | [] |
NCT03686397 | 7.2.1.7 | Protocol Deviations Due to an Emergency or Adverse Event | 7.2.1.7 Protocol Deviations Due to an Emergency or Adverse Event In the case of an emergency or AE, departures from the protocol may be necessary. Such protocol deviations will be determined as allowable on a case-by-case basis. The Investigator or other physician in attendance in such an emergency must contact the Med... | [] |
NCT03686397 | 7.2.2 | Pregnancy Reporting | 7.2.2 Pregnancy Reporting If a patient becomes pregnant during the study or within the safety follow-up period defined in the protocol, the Investigator will stop dosing with study drug(s) immediately and the patient will be withdrawn from the study. Early termination procedures will be implemented at that time. report... | [] |
NCT03686397 | 8 | STUDY CONDUCT | 8. STUDY CONDUCT | [] |
NCT03686397 | 8.1 | Schedule of Observations | 8.1 Schedule of Observations A schedule of observations and assessments to be performed during the study is provided in Table 1. Table 1 Schedule of Observations | STUDY CONDUCTSchedule of ObservationsA schedule of observations and assessments to be performed during the study is provided inTable 1. | | | | | |---------... | [] |
NCT03686397 | 8.2 | Observations by Visit 8.2.1 Visit 1 | 8.2 Observations by Visit 8.2.1 Visit 1 Patients who may be eligible to participate in the study will be offered the opportunity to participate. The study will be explained to them and questions about the study will be answered. Patients who elect to participate will sign the Informed Consent Form (or have it signed by... | [] |
NCT03686397 | 8.2.5 | Study Termination | 8.2.5 Study Termination If the Sponsor or their desighee, the Investigator, or the Medical Monitor discovers conditions arising during the study that indicate the study should be halted, the study may be terminated. Conduct of the study may also be terminated at a particular study site while the study continues at othe... | [] |
NCT03686397 | 9 | DATA HANDLING AND RECORD KEEPING | 9. DATA HANDLING AND RECORD KEEPING | [] |
NCT03686397 | 9.1 | Data Quality Assurance | 9.1 Data Quality Assurance The Sponsor (or Sponsor's designee) will conduct a site visit to verify the qualifications of each Investigator, inspect the site facilities, and inform the Investigator of his or her responsibilities and the procedures for ensuring adequate and correct documentation. An Investigator Meeting ... | [] |
NCT03686397 | 9.2 | Case Report Forms and Source Documentation | 9.2 Case Report Forms and Source Documentation Electronic Data Capture (EDC) will be used in this study. The Sponsor or designee will provide a password to each staff member who has the authorization to implement the EDC. The electronic data for each patient will be checked against source documents at the study site by... | [] |
NCT03686397 | 9.3 | Archiving Study Records | 9.3 Archiving Study Records Essential documents should be retained for a minimum of 25 years after the last approval of a marketing application in an ICH region, and until there are no pending or contemplated marketing applications in an ICH region or at least 25 years have elapsed since the formal discontinuation of c... | [] |
NCT03686397 | 9.4 | Sample Retention | 9.4 Sample Retention Samples may be used for purpose related to research. The samples may be stored until the sponsor has determined that the specimens are no longer needed, and the decision has been made that there are no samples to be re-assayed. In addition, identifiable sample can be destroyed at any time at the re... | [] |
NCT03686397 | 10 | STATISTICAL METHODS | 10. STATISTICAL METHODS | [] |
NCT03686397 | 10.1 | General Statistical Methods | 10.1 General Statistical Methods All data collected in the database will be presented in the data listings. Continuous data will be summarized by treatment group using descriptive statistics (n, mean, standard deviation, standard error of the mean, median, minimum, and maximum). Categorical data will be tabulated by tr... | [] |
NCT03686397 | 10.1.1 | Sample Size | 10.1.1 Sample Size Planned enrollment is 191 patients randomized in 2:1 ratio (Clotrimazole 1% otic solution: Placebo) to obtain 150 evaluable patients (100 Clotrimazole 1% and 50 Placebo). Clotrimazole otic solution should be statistically superior to the placebo (p<0.05) with regard to the therapeutic cure at the tes... | [] |
NCT03686397 | 10.1.2 | Interim Analyses | 10.1.2 Interim Analyses No interim analyses are planned. | [] |
NCT03686397 | 10.1.3 | Missing, Unused, and Spurious Data | 10.1.3 Missing, Unused, and Spurious Data Patients with missing efficacy data or indeterminate outcomes will be considered as treatment failures for efficacy analyses. For the primary and secondary endpoints, patients who discontinue for lack of efficacy or rescue medication will be considered as treatment failures. Al... | [] |
NCT03686397 | 10.1.5 | Patient Disposition | 10.1.5 Patient Disposition The numbers of patients in each treatment group who completed the study and who terminated early will be tabulated. For patients who terminated early, primary and secondary reasons for termination will be tabulated. Patients who were excluded from each of the study populations defined in Sect... | [] |
NCT03686397 | 10.1.6 | Demographics and Baseline Characteristics | 10.1.6 Demographics and Baseline Characteristics Continuous demographic and baseline characteristics, such as age, will be summarized by treatment group with descriptive statistics (n, mean, standard deviation, standard error of the mean, median, minimum, and maximum). Categorical demographic and baseline characteristi... | [] |
NCT03686397 | 10.1.7 | Protocol Deviations | 10.1.7 Protocol Deviations Protocol deviations are defined as violations from the procedures outlined in the protocol. Major protocol deviations are protocol violations likely to affect the study results and leading to the exclusion of the subject from the MPP. Once the database has been completed and considered as "cl... | [] |
NCT03686397 | 10.1.8 | Compliance with Study Medication | 10.1.8 Compliance with Study Medication Compliance will be assessed by a review of the number of vials returned. The number of doses the patient actually took during the treatment period will be divided by the number of doses the patient was expected to have taken. The resulting ratio will be multiplied by 100% to dete... | [] |
NCT03686397 | 10.1.9 | Concomitant Medications | 10.1.9 Concomitant Medications Concomitant medications will be tabulated by treatment group. | [] |
NCT03686397 | 10.1.10 | Efficacy Analyses | 10.1.10 Efficacy Analyses For the efficacy analyses, only the assessments from the evaluable ear will be used. Version 2.0 A#1; 31 October 2019 51 of 63 Confidential  | [] |
NCT03686397 | 10.1.10.1 | Primary efficacy endpoint | 10.1.10.1 Primary efficacy endpoint
Primary analysis of the primary endpoint The primary endpoint for efficacy will be the proportion of subjects with therapeutic cure at test-ofcure (Visit 4). Therapeutic cure is defined as both mycological cure and clinical cure. Mycological cure is defined as eradication (culture d... | [
"Primary analysis of the primary endpoint",
"Secondary analyses of the primary endpoint",
"Sensitivity Analyses of the primary endpoint"
] |
NCT03686397 | 10.1.10.2 | Secondary efficacy endpoints | 10.1.10.2 Secondary efficacy endpoints Analysis of the secondary efficacy endpoints will be supportive only: - e Overall clinical cure at Visits 2, 3 and 4. - e Mycological cure at Visits 3 and 4. - e Therapeutic cure at Visit 2 and 3. - e Changes in signs/symptoms at Visits 2, 3 and 4. Changes in each sign/symptom (pr... | [] |
NCT03686397 | 10.1.10.2.1 | Mycological outcome | 10.1.10.2.1 Mycological outcome The proportion of patients with a response of Eradication or Presumed Eradication at Visit 2, Visit 3 (EOT) and Visit 4 (TOC) will be compared between the Clotrimazole 1% otic solution and the Placebo treatment groups by using a chi-squared test. Mycological outcome will be summarized by... | [] |
NCT03686397 | 10.1.10.2.2 | Changes in signs/symptoms | 10.1.10.2.2 Changes in signs/symptoms The frequency of patients (n,%) with signs/symptoms (pruritus, otalgia, ear fullness and otorrhea) assessed by the investigator as "Absent", "Mild", "Moderate" or "Severe" will be summarized at V1, V2, V3, and V4. The change from V1 in each sign and symptom will be assessed and cla... | [] |
NCT03686397 | 10.1.10.3 | Additional analysis | 10.1.10.3 Additional analysis | [] |
NCT03686397 | 10.1.10.3.1 | Antimycological susceptibility | 10.1.10.3.1 Antimycological susceptibility Antifungal susceptibility against clotrimazole and comparators will be tested. Interpretation of antimycological susceptibility by baseline pathogen will also be provided. | [] |
NCT03686397 | 10.1.11 | Safety Analyses | 10.1.11 Safety Analyses All safety analyses will be based on the Safety population. Adverse events, the data analyzed with respect to incidence as well as severity and potential relationship of the AEs to study medication will be monitored during the study. Safety will be assessed by reports of AEs and physical examina... | [] |
NCT03686397 | 10.2 | Changes in Statistical Methods | 10.2 Changes in Statistical Methods Any deviation(s) from the original Statistical Analysis Plan will be described and justified in the final study report. Version 2.0 A#1; 31 October 2019 54 of 63 Confidential  | [] |
NCT03686397 | 11 | ETHICS, LEGAL, AND ADMINISTRATIVE ASPECTS | 11. ETHICS, LEGAL, AND ADMINISTRATIVE ASPECTS | [] |
NCT03686397 | 11.1 | Good Clinical Practice | 11.1 Good Clinical Practice The procedures described in this study protocol are designed to ensure that the Sponsor and Investigator abide by the principles of the Good Clinical Practice (GCP) guidelines of the ICH and of the Declaration of Helsinki (shown in Appendix 1). The study also will be performed in keeping wit... | [] |
NCT03686397 | 11.2 | Informed Consent | 11.2 Informed Consent Before being admitted to the study, each patient, or patient's legally authorized representative, will provide informed consent according to the regulatory and legal requirements of the participating country. The Investigator will not undertake any procedure specifically required for the clinical ... | [] |
NCT03686397 | 11.3 | Approval of Study Protocol | 11.3 Approval of Study Protocol Before the start of the study, the study protocol and other appropriate documents will be submitted to the IRB/IEC. Written approval from the IRB/IEC must be obtained before any patients are screened. The study protocol and other appropriate documents will be submitted to other authoriti... | [] |
NCT03686397 | 11.4 | Amending the Protocol | 11.4 Amending the Protocol This protocol is to be followed exactly. To alter the protocol, amendments must be written, receive approval from all persons who approved the original protocol, and receive IRB/IEC approval prior to implementation. Following approval, the protocol amendment(s) will be submitted to the Invest... | [] |
NCT03686397 | 11.5 | Confidentiality | 11.5 Confidentiality All study findings and documents will be regarded as confidential. The Investigator and members of his/her research team must not disclose such information without prior written approval from the Sponsor. The anonymity of participating patients must be maintained. Patients will be identified on EDC... | [] |
NCT03686397 | 11.6 | Liability and Insurance | 11.6 Liability and Insurance The Sponsor will take out reasonable third-party liability insurance cover in accordance with all local legal requirements, without prejudice to the liability insurance corresponding to the Investigator, the persons instructed by the Investigator, and the hospital, practice, or institute in... | [] |
NCT03686397 | 11.7 | Publication Policy | 11.7 Publication Policy The clinical study report will be a presentation of the pooled results, which will be prepared by the Sponsor with the assistance of some or all of the investigators. An Investigator shall not publish any data (poster, abstract, paper, etc.) without having obtained written approval from the Spon... | [] |
NCT03686397 | 12 | REFERENCES | 12. REFERENCES - 1. Vennewald |, Klemm E. Otomycosis: Diagnosis and treatment. Clin Dermatol. 2010;28:202- 11. - 2. Osguthorpe JD1, Nielsen DR. Otitis externa: Review and clinical update. Am Fam Physician. 2006; 74:1510-6. - 3. Schaefer P, Baugh RF. Acute otitis externa: an update. Am Fam Physician. 2012; 86:1055- 61. ... | [] |
NCT03686397 | 13 | APPENDICES | 13. APPENDICES
Appendix 1 Declaration of Helsinki
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th W... | [
"Appendix 1 Declaration of Helsinki",
"WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI",
"Ethical Principles for Medical Research Involving Human Subjects",
"PREAMBLE",
"GENERAL PRINCIPLES",
"RISKS, BURDENS AND BENEFITS",
"VULNERABLE GROUPS AND INDIVIDUALS",
"SCIENTIFIC REQUIREMENTS AND RESEARCH PRO... |
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