protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02612779 | 8.1.2 | EN Cohort | 8.1.2 EN Cohort The planned sample size will be approximately 30 treated subjects; screening will continue until a minimum of 30 patients are enrolled and treated. For a 30% observed ORR rate and a sample size of N=30 yields an exact confidence interval of [0.15, 0.49]. These design parameters ensure a lower bound high... | [] |
NCT02612779 | 8.2 | Populations for Analyses | 8.2 Populations for Analyses • The safety analysis set consists of subjects who receive at least one dose of study drug. The safety analysis set is also the all treated analysis set. • The efficacy analysis set is the same as the all treated analysis set. | [] |
NCT02612779 | 8.3 | Endpoints | 8.3 Endpoints | [] |
NCT02612779 | 8.3.1 | Primary Endpoint(s) | 8.3.1 Primary Endpoint(s) | [] |
NCT02612779 | 8.3.1.1 | EPd Cohort | 8.3.1.1 EPd Cohort PFS is defined as the time from first dosing date to the date of the first documented progression per IMWG uniform criteria or death due to any cause, whichever occurs first. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjec... | [] |
NCT02612779 | 8.3.1.2 | EN Cohort | 8.3.1.2 EN Cohort ORR is defined as proportion of subjects with best overall response of partial response (PR) or better. Response will be determined per IMWG uniform criteria. | [] |
NCT02612779 | 8.3.2 | Secondary Endpoint(s) | 8.3.2 Secondary Endpoint(s) | [] |
NCT02612779 | 8.3.2.1 | EPd Cohort | 8.3.2.1 EPd Cohort - ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better. - OS is defined as the time from first dosing date to the date of death from any cause. A subject who has not died will be censored at last known date alive. | [] |
NCT02612779 | 8.3.2.2 | EN Cohort | 8.3.2.2 EN Cohort - PFS definition: See Section 8.3.1.1 - OS is defined as the time from first dosing date to the date of death from any cause. A subject who has not died will be censored at last known date alive.   | [] |
NCT02612779 | 8.4 | Analyses | 8.4 Analyses | [] |
NCT02612779 | 8.4.1 | Demographics and Baseline Characteristics | 8.4.1 Demographics and Baseline Characteristics The demographic and baseline characteristics of patients in the safety analysis set will be presented. Among the baseline clinical characteristics are patients' ECOG Performance Status, baseline laboratory assessment for safety and efficacy endpoints, number of prior line... | [] |
NCT02612779 | 8.4.2 | Efficacy Analyses | 8.4.2 Efficacy Analyses The efficacy endpoints, PFS and ORR, will be defined using the IMWG criteria. Responses will be assessed at every treatment cycle using central laboratory test results on myeloma urine and serum, local laboratory bone marrow aspiration test, and if needed bone marrow and skeletal survey results ... | [] |
NCT02612779 | 8.4.3 | Safety Analyses | 8.4.3 Safety Analyses Safety assessments will be performed prior, during and between dosing, and up to 100 days after the last treatment for the EN cohort and 60 days after the last dose in the EPd cohort and for subjects in the EN cohort who cross-over to the EPd cohort but discontinue treatment within 2 cycles of EPd... | [] |
NCT02612779 | 8.4.6 | Outcomes Research Analyses (both cohorts) | 8.4.6 Outcomes Research Analyses (both cohorts) Not applicable. | [] |
NCT02612779 | 8.5 | Interim Analyses | 8.5 Interim Analyses Administrative interim analyses may be performed at several times prior to completion of the study in order to facilitate program decisions and to support presentations or publications. | [] |
NCT02612779 | 9 | STUDY MANAGEMENT | 9. STUDY MANAGEMENT | [] |
NCT02612779 | 9.1 | Compliance | 9.1 Compliance | [] |
NCT02612779 | 9.1.1 | Compliance with the Protocol and Protocol Revisions | 9.1.1 Compliance with the Protocol and Protocol Revisions The study shall be conducted as described in this approved protocol. All revisions to the protocol must be discussed with, and be prepared by, BMS. The investigator should not implement any deviation or change to the protocol without prior review and documented ... | [] |
NCT02612779 | 9.1.2 | Monitoring | 9.1.2 Monitoring BMS representatives will review data centrally to identify potential issues to determine a schedule of on-site visits for targeted review of study records. Representatives of BMS must be allowed to visit all study site locations periodically to assess the data quality and study integrity. On site they ... | [] |
NCT02612779 | 9.1.2.1 | Source Documentation | 9.1.2.1 Source Documentation The Investigator is responsible for ensuring that the source data are accurate, legible, contemporaneous, original and attributable, whether the data are hand-written on paper or entered electronically. If source data are created (first entered), modified, maintained, archived, retrieved, o... | [] |
NCT02612779 | 9.1.3 | Investigational Site Training | 9.1.3 Investigational Site Training Bristol-Myers Squibb will provide quality investigational staff training prior to study initiation. Training topics will include but are not limited to: GCP, AE reporting, study details and procedure, electronic CRF/eCRFs, study documentation, informed consent, and enrollment of WOCB... | [] |
NCT02612779 | 9.2 | Records | 9.2 Records | [] |
NCT02612779 | 9.2.1 | Records Retention | 9.2.1 Records Retention The investigator must retain all study records and source documents for the maximum period required by applicable regulations and guidelines, or institution procedures, or for the period specified by BMS, whichever is longer. The investigator must contact BMS prior to destroying any records asso... | [] |
NCT02612779 | 9.2.2 | Study Drug Records | 9.2.2 Study Drug Records It is the responsibility of the investigator to ensure that a current disposition record of study drug (inventoried and dispensed) is maintained at the study site for all investigational products. Records or logs must comply with applicable regulations and guidelines and should include: - amoun... | [] |
NCT02612779 | 9.2.3 | Case Report Forms | 9.2.3 Case Report Forms An investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the investigation on each individual treated or entered as a control in the investigation. Data that are derived from source documents and repo... | [] |
NCT02612779 | 9.3 | Clinical Study Report and Publications | 9.3 Clinical Study Report and Publications A Signatory Investigator must be selected to sign the clinical study report. For this protocol, the Signatory Investigator will be selected as appropriate based on the following criteria: - Subject recruitment (eg, among the top quartile of enrollers) - Involvement in trial de... | [] |
NCT02612779 | 10 | GLOSSARY OF TERMS | 10. GLOSSARY OF TERMS | Term | Definition | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02612779 | 11 | LIST OF ABBREVIATIONS | 11. LIST OF ABBREVIATIONS | Term | Definition | |---------|------------------------------------------------------------------------| | ACTH | adrenocorticotropic Hormone | | ADCC | antibody-dependent cell-mediated cytotoxicity | | AE | adverse event | | AIDS | acquired immunodeficiency syndrome | | ALT | alanine aminot... | [
"APPENDIX 1 DEFINITION OF LINES OF THERAPY",
"APPENDIX 2 PERFORMANCE STATUS SCALES",
"APPENDIX 3 PREPARATION AND ADMINISTRATION OF ELOTUZUMAB",
"Dose Preparation Instructions",
"Reconstitute elotuzumab lyophilized study drug, as described in steps 1 to 5.",
"Administration Instructions",
"Elotuzumab Inf... |
NCT02660138 | 1 | BACKGROUND INFORMATION | 1 BACKGROUND INFORMATION | [] |
NCT02660138 | 1.1 | Introduction | 1.1 Introduction Dysport® contains botulinum toxin type A (BTX-A) neurotoxin complex derived from the bacterium Clostridium botulinum. It prevents acetylcholine release at neuromuscular junctions, blocking neuronal transmission which in turn results in weakness or paresis of the injected muscle. Over a period of months... | [] |
NCT02660138 | 1.1.1 | Disease Review | 1.1.1 Disease Review The central and peripheral nervous systems control storage of urine in the bladder and also control voiding to eliminate the urine. During the bladder cycle storage phase in healthy adults, inhibitory neuronal signals prevent detrusor muscle contraction, while excitatory inputs keep the urethral sp... | [] |
NCT02660138 | 1.1.2 | Medical Management and Unmet Need | 1.1.2 Medical Management and Unmet Need The goals of treatment of NDO are: - Treating UI and thus improving QoL - Reducing bladder pressure to prevent upper urinary tract damage. The current first line pharmacologic treatment for NDO consists of oral medications such as anticholinergics, which are often used in conjunc... | [] |
NCT02660138 | 1.2 | Name and Description of Investigational Medicinal Product | 1.2 Name and Description of Investigational Medicinal Product BTX-A is a potent neurotoxin isolated from the bacterium Clostridium botulinum, a grampositive, spore-forming anaerobe. BTX-A, a single chain protein with a molecular weight of approximately 150000 Daltons (Da), is one of seven different serotypes (classed A... | [] |
NCT02660138 | 1.3 | Findings from Nonclinical and Clinical Studies | 1.3 Findings from Nonclinical and Clinical Studies | [] |
NCT02660138 | 1.3.1 | Summary of Nonclinical Studies | 1.3.1 Summary of Nonclinical Studies An extensive nonclinical development program for Dysport® exists, including pharmacology, distribution, and toxicology studies (including repeat use). In this program, animals were treated by intramuscular administration of Dysport® in striated muscles (gluteus and gastrocnemius mus... | [] |
NCT02660138 | 1.3.2 | Summary of Clinical Studies | 1.3.2 Summary of Clinical Studies The efficacy of Dysport® as a treatment of UI related to NDO has been reported in several published studies [\[10,](#page-109-10) [11,](#page-109-11) [12,](#page-109-12) [13,](#page-109-13) [14,](#page-109-14) [15,](#page-109-15) [16\]](#page-110-0). Administered doses were 500 U, 750 ... | [] |
NCT02660138 | 1.4 | Known and Potential Risks and Benefits to Human Subjects | 1.4 Known and Potential Risks and Benefits to Human Subjects Dysport® was first approved for the treatment of blepharospasm and hemifacial spasm in the United Kingdom in 1990. Since then Dysport® has been approved in over 80 countries for a PROTOCOL: FINAL: 16 APRIL 2018 PAGE 31/131 range of indications. The posology a... | [] |
NCT02660138 | 1.5 | Selection of Investigational Medicinal Products and Dosages | 1.5 Selection of Investigational Medicinal Products and Dosages Published data provide information from over 400 patients with NDO treated with doses ranging from 500 to 1000 U Dysport®. Across a number of clinical studies, all doses were reported as efficacious. However, the 500 U dose has been reported to be less eff... | [] |
NCT02660138 | 1.6 | Population to be Studied | 1.6 Population to be Studied This study will recruit adult subjects with UI caused by NDO due to either SCI or MS, who have not been adequately managed with oral medication. In order to ensure a homogenous population of subjects with SCI and MS for efficacy and safety assessments, all subjects will be required to be ro... | [] |
NCT02660138 | 1.7 | Placebo Usage During Treatment 1 | 1.7 Placebo Usage During Treatment 1 The use of placebo during the first IMP treatment administration ensures a rigorous, scientifically appropriate study design to assess the efficacy and safety of Dysport® in the treatment of UI due to NDO. The use of placebo is justified because: - Although UI due to NDO is a sympto... | [] |
NCT02660138 | 2 | PURPOSE OF THE STUDY AND STUDY OBJECTIVES | 2 PURPOSE OF THE STUDY AND STUDY OBJECTIVES | [] |
NCT02660138 | 2.1 | Purpose of the Study | 2.1 Purpose of the Study Dysport® is currently not registered in the indication of NDO. Following the positive outcome of the phase IIa proof-of-concept Study (Y-52-52120-155) [\[17\]](#page-110-1), this phase III study is intended to provide confirmatory evidence of the safety and efficacy of Dysport® for the treatmen... | [] |
NCT02660138 | 2.2 | Study Objectives | 2.2 Study Objectives
Target Population: Subjects with UI caused by NDO due to either SCI or MS, who have not been adequately managed with oral medication and who routinely require CIC to manage their bladder function. Primary Study Objective: • To assess the efficacy of two Dysport® doses (600 U and 800 U), compared t... | [
"Target Population:",
"Secondary Study Objectives:"
] |
NCT02660138 | 3 | STUDY DESIGN | 3 STUDY DESIGN | [] |
NCT02660138 | 3.1 | General Design and Study Schema | 3.1 General Design and Study Schema This is a phase III, multicentre, randomised, double blind, parallel group, placebo controlled study to assess the efficacy and safety of two doses of Dysport® (600 U and 800 U) in adult subjects with SCI or MS with UI due to NDO, who have not been adequately managed with oral medica... | [] |
NCT02660138 | 3.2 | Primary and Secondary Endpoints and Evaluations | 3.2 Primary and Secondary Endpoints and Evaluations | [] |
NCT02660138 | 3.2.1 | Primary Efficacy Endpoint and Evaluations | 3.2.1 Primary Efficacy Endpoint and Evaluations Mean change from study Baseline (assessed at Screening) to Week 6 after the first IMP administration in the weekly number of UI episodes: • measured on a 7-day bladder diary. Seven-day bladder diaries that contain data recorded on at least 5 days will be included in the a... | [] |
NCT02660138 | 3.2.2 | Secondary Efficacy Endpoints and Evaluations | 3.2.2 Secondary Efficacy Endpoints and Evaluations | [] |
NCT02660138 | 3.2.2.1 | Overview of Secondary Measures | 3.2.2.1 Overview of Secondary Measures Mean change from study Baseline (assessed at Screening) or from treatment cycle baseline (assessed at Retreatment Assessment Visit) to post-treatment timepoints (timepoints listed in [Table](#page-47-0) 4 and [Table](#page-49-0) 5): - Bladder diary measures: - weekly number of UI ... | [] |
NCT02660138 | 3.2.2.2 | Hierarchical Analysis of Secondary Endpoints | 3.2.2.2 Hierarchical Analysis of Secondary Endpoints A hierarchical analysis will be performed in the order listed for the following secondary efficacy endpoints at Week 6 after the first IMP administration: - 1) Mean change from study Baseline (assessed at Screening) in the MCC: - measured by urodynamic filling cystom... | [] |
NCT02660138 | 3.2.3 | Safety Endpoints and Evaluations | 3.2.3 Safety Endpoints and Evaluations Safety will be assessed throughout the study by evaluating: - AEs - vital signs - laboratory blood parameters (haematology and serum chemistry) - laboratory urine parameters (laboratory urinalysis/microscopy, culture and sensitivity) - development of BTX-A antibodies - usage of co... | [] |
NCT02660138 | 3.3 | Randomisation and Blinding | 3.3 Randomisation and Blinding | [] |
NCT02660138 | 3.3.1 | Randomisation | 3.3.1 Randomisation The randomisation will be done in a 2:2:1:1 ratio to one of four treatment sequences: | Sequence | Subjects | Treatment 1 | Subsequent retreatment(s) | |----------|--------------|----------------|---------------------------| | 1 | 110 subjects | 600 U Dysport® | 600 U Dysport® | | 2 | 110 subjects |... | [] |
NCT02660138 | 3.3.2 | Blinding of Investigational Medicinal Product | 3.3.2 Blinding of Investigational Medicinal Product All IMP administrations, including retreatments, will be double blind, although only the first treatment is placebo controlled. Subjects, investigators and all study staff will remain blinded to treatment assignment throughout the study.  | [] |
NCT02660138 | 3.3.3 | Maintenance of Randomisation and Blinding | 3.3.3 Maintenance of Randomisation and Blinding The dose(s) administered as allocated by the randomisation sequence should remain blinded throughout the study. However, in the event of an SAE or unexpected AE, which requires the identification of the study treatment group, the investigator should first contact the phar... | [] |
NCT02660138 | 3.4 | Study Duration | 3.4 Study Duration For subjects, the study will consist of a Screening period for up to 30 days (but can be extended in certain circumstances, see Section [5.2.1\)](#page-51-1), with randomisation at the Treatment Visit (Day 1) up to 14 days later (can be extended if UTI prevents IMP administration - see Section 5.2.3)... | [] |
NCT02660138 | 3.5 | Stopping Rules and Discontinuation Criteria | 3.5 Stopping Rules and Discontinuation Criteria During the conduct of the study, SAEs will be reviewed (see Section [8.1.4\)](#page-87-2) as they are reported from the study sites to identify safety concerns. The sponsor may terminate this study at any time. Reasons for termination include but are not limited to: - The... | [] |
NCT02660138 | 3.6 | Source Data Recorded on the Case Report Form | 3.6 Source Data Recorded on the Case Report Form Data will be collected by using an eCRF in compliance with Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11. As required by Good Clinical Practice (GCP), the sponsor-assigned or sponsor designee-assigned monitor will verify, by direct refer... | [] |
NCT02660138 | 4 | SELECTION AND WITHDRAWAL OF SUBJECTS | 4 SELECTION AND WITHDRAWAL OF SUBJECTS | [] |
NCT02660138 | 4.1 | Inclusion Criteria | 4.1 Inclusion Criteria The following inclusion criteria will be assessed at the beginning of the Screening process: - 1) Written informed consent prior to any study related procedure. - 2) Male or female, aged 18 to 80 years inclusive. - 3) UI for at least 3 months prior to Screening as a result of NDO due to SCI or MS... | [] |
NCT02660138 | 4.2 | Exclusion Criteria | 4.2 Exclusion Criteria The following exclusion criteria will be assessed throughout the Screening process: 1) Any current condition (other than NDO) that may impact on bladder function, CCI - 2) Previous or current, tumour or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI. - ... | [] |
NCT02660138 | 4.3 | Retreatment Criteria | 4.3 Retreatment Criteria For a study retreatment to occur all of the below retreatment criteria must be met. Assessed prior to or during the Retreatment Assessment Visit: - 1) Retreatment requested by subject; - 2) More than 12 weeks (84 days) since the previous IMP administration; - 3) CCI - 5) In the investigator's o... | [] |
NCT02660138 | 4.4 | Subject Withdrawal Criteria and Procedures | 4.4 Subject Withdrawal Criteria and Procedures In accordance with the Declaration of Helsinki (in accordance with the applicable country's acceptance), each subject is free to withdraw from the study at any time. The investigator also has the right to withdraw a subject from the study in the event of concurrent illness... | [] |
NCT02660138 | 5 | STUDY PROCEDURES | 5 STUDY PROCEDURES | [] |
NCT02660138 | 5.1 | Study Schedule | 5.1 Study Schedule The schedule of procedures and assessments during the study is summarised in [Table](#page-47-0) 4 for Screening and Treatment 1 follow-up and in [Table](#page-49-0) 5 for retreatment assessment and follow-up. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 48/131 Table 4 Study Procedures and Assessments for Fir... | [
"IPSEN GROUP D-FR-52120-222 CONFIDENTIAL",
"IPSEN GROUP D-FR-52120-222 CONFIDENTIAL"
] |
NCT02660138 | 5.2 | Study Visits | 5.2 Study Visits | [] |
NCT02660138 | 5.2.1 | Screening Period | 5.2.1 Screening Period The Screening period (Days -30 to -1) consists of two study visits: - Screening Visit 1 - Screening Visit 2. The time to Screening Visit 2 can be extended to more than 30 days to obtain an appropriately and fully completed bladder diary or to obtain a valid bladder diary (see Section 17.6). In ad... | [] |
NCT02660138 | 5.2.1.1 | Screening Visit 1 | 5.2.1.1 Screening Visit 1 The suggested order of procedures for Screening Visit 1 is shown in [Table](#page-51-3) 6. Table 6 Order of Procedures for Screening Visit 1 | Suggested order of procedures | Comment | Details ofprocedure | |---------------------------------------------------|----------------------------------... | [] |
NCT02660138 | 5.2.1.2 | Screening Visit 2 | 5.2.1.2 Screening Visit 2 Electronic bladder diary data may be reviewed by the site prior to Screening Visit 2. If there has been no issue with bladder diary completion (see Section 17.6) and the subject is ineligible (inclusion criterion #13, inclusion criterion #14, and exclusion criterion #28) then the subject may b... | [] |
NCT02660138 | 5.2.2 | Procedures for Screening and Enrolment | 5.2.2 Procedures for Screening and Enrolment | [] |
NCT02660138 | 5.2.2.1 | Informed Consent | 5.2.2.1 Informed Consent Signed and dated informed consent must be obtained prior to performing any Screening procedures. After informed consent is obtained, subjects will be allocated a subject number. All screened subjects must be identifiable throughout the study. The investigator will maintain a list of subject num... | [] |
NCT02660138 | 5.2.2.2 | Other Data to be Collected at Screening | 5.2.2.2 Other Data to be Collected at Screening For full details of data collection refer to the eCRF completion guide. Data will be collected for the following variables: - Demographic data - Date or year of birth, sex, race, and ethnicity according to local regulations - Medical/surgical/NDO history In particular rel... | [] |
NCT02660138 | 5.2.2.3 | Urinary Tract Ultrasound at Screening | 5.2.2.3 Urinary Tract Ultrasound at Screening This is only required if the subject does not have an adequate documented urinary tract ultrasound available from within 6 months prior to Screening which confirms that no medical issues exist that would preclude entry into the study (e.g. bladder stones or unexplained rena... | [] |
NCT02660138 | 5.2.3 | Treatment Visit (Day 1) | 5.2.3 Treatment Visit (Day 1) The Treatment Visit should be performed within 14 days of Screening Visit 2. However, where a UTI occurs and impacts the ability to perform IMP administration the time to the Treatment Visit can be extended until the UTI is resolved. The suggested order of procedures for the Treatment Visi... | [] |
NCT02660138 | 5.2.4 | Follow-up Period (after First Treatment and Retreatments) | 5.2.4 Follow-up Period (after First Treatment and Retreatments) Routine Follow-up Visits after the first treatment and after retreatments are almost identical, therefore visit details in this section refers to follow-up for both the first treatment and retreatments (any differences in follow-up will be highlighted). | [] |
NCT02660138 | 5.2.4.1 | Week 1 and Week 4 Telephone Visits | 5.2.4.1 Week 1 and Week 4 Telephone Visits The subject should be contacted by telephone and the following should be discussed. Telephone Visits may be conducted as clinic visits if required, in the investigator's opinion. The suggested order of procedures for Week 1 and Week 4 Telephone Visits is shown in [Table](#page... | [] |
NCT02660138 | 5.2.4.2 | Week 2 Clinic Visit | 5.2.4.2 Week 2 Clinic Visit The suggested order of procedures for Week 2 Clinic Visit is shown in [Table](#page-55-4) 10. Table 10 Order of procedures for Week 2 Clinic Visit | Suggested order of procedures | Comment | Details ofprocedure | |------------------------------------------------|-----------------------------... | [] |
NCT02660138 | 5.2.4.3 | Week 6 Clinic Visit after First Treatment | 5.2.4.3 Week 6 Clinic Visit after First Treatment The Week 6 Visit following the first study treatment is the primary study timepoint. The suggested order of procedures shown in [Table](#page-56-2) 11 is to be performed at the Week 6 Visit following the first study treatment. For activities required at the Week 6 Visit... | [] |
NCT02660138 | 5.2.4.4 | Week 6 Clinic Visit after Retreatments | 5.2.4.4 Week 6 Clinic Visit after Retreatments The suggested order of procedures in [Table](#page-57-1) 12 is to be performed at the Week 6 Visit following any retreatment. For activities required at the Week 6 Visit after the first treatment, refer to Section [5.2.4.3.](#page-56-0) PROTOCOL: FINAL: 16 APRIL 2018 PAGE ... | [] |
NCT02660138 | 5.2.4.5 | Week 12 Clinic Visit | 5.2.4.5 Week 12 Clinic Visit The suggested order of procedures for Week 12 Clinic Visit is shown in [Table](#page-58-1) 13. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 59/131 Table 13 Order of Procedures for Week 12 Clinic Visit | Suggested order of procedures | Comment | Details ofprocedure | |--------------------------------... | [] |
NCT02660138 | 5.2.4.6 | Routine Telephone Visits Every 12 weeks | 5.2.4.6 Routine Telephone Visits Every 12 weeks The subject should be contacted by telephone and the following should be discussed. Telephone Visits may be conducted as clinic visits if required, in the investigator's opinion. The suggested order of procedures for Routine Telephone Visits every 12 weeks is shown in [Ta... | [] |
NCT02660138 | 5.2.5 | Retreatment Period | 5.2.5 Retreatment Period Subjects may request retreatment after a minimum of 12 weeks following the previous treatment. Retreatment request may occur at: - A scheduled Telephone Follow-up Visit: - eligibility for retreatment to be assessed as far as possible - Retreatment Assessment Visit to be scheduled if the subject... | [] |
NCT02660138 | 5.2.5.1 | Retreatment Request at a Scheduled Telephone Follow-up Visit | 5.2.5.1 Retreatment Request at a Scheduled Telephone Follow-up Visit If the subject requests retreatment at a scheduled Telephone Visit, a preliminary assessment of eligibility should be performed to the extent possible by telephone, based on current (commenced within 14 days prior to the scheduled Telephone Visit) ele... | [] |
NCT02660138 | 5.2.5.2 | Retreatment Request during an unscheduled contact | 5.2.5.2 Retreatment Request during an unscheduled contact If it has been more than 12 weeks since the last IMP administration, and the subject requests retreatment between scheduled visits then the subject should be asked to commence the 7-day bladder diary collection. As soon as possible after completing the diary, th... | [] |
NCT02660138 | 5.2.5.3 | Retreatment Request at a scheduled Clinic Follow-up Visit | 5.2.5.3 Retreatment Request at a scheduled Clinic Follow-up Visit If the subject requests retreatment at a scheduled visit, a preliminary assessment of eligibility should be performed as far as possible based on current (commenced within 14 days prior to the scheduled clinic visit) electronic 7-day bladder diary data a... | [] |
NCT02660138 | 5.2.5.4 | Retreatment Assessment Visit | 5.2.5.4 Retreatment Assessment Visit The suggested order of procedures for Retreatment Assessment Visit is shown in [Table](#page-61-1) 15. PROTOCOL: FINAL: 16 APRIL 2018 PAGE 62/131 Table 15 Order of Procedures for Retreatment Assessment Visit | | Suggested order of procedures | Comment | Details ofprocedure | |-----|... | [] |
NCT02660138 | 5.2.6 | Retreatment Visit | 5.2.6 Retreatment Visit The Retreatment Visit should ideally be performed within 14 days of confirmed eligibility for retreatment. It may be performed on the same day as the Retreatment Assessment Visit only if urine culture was taken and prophylactic antibiotics (empiric or adapted) were commenced at least 3 days prio... | [] |
NCT02660138 | 5.2.7 | End of Study Visit or Early Withdrawal Visit | 5.2.7 End of Study Visit or Early Withdrawal Visit The procedures at an EOS Visit and an Early Withdrawal Visit are identical. For those subjects completing the study, the EOS Visit will occur: - 104 weeks after the first IMP administration; if it has been more than 12 weeks since the previous IMP administration - At t... | [] |
NCT02660138 | 6.1.3.1 | Investigational Medicinal Product Storage and Security | 6.1.3.1 Investigational Medicinal Product Storage and Security The investigator, or an approved representative (e.g. pharmacist), will ensure that all IMP and any other study-related material is stored in a secured area, under recommended temperature monitored storage conditions, in accordance with applicable regulator... | [] |
NCT02660138 | 6.1.3.2 | Investigational Medicinal Product Preparation | 6.1.3.2 Investigational Medicinal Product Preparation The IMP will be reconstituted at the investigational site with sterile, preservative-free, sodium chloride for injection (0.9%); to a total volume of 15 mL. The method of reconstitution and preparation is identical regardless of the treatment assignment (800 U Dyspo... | [] |
NCT02660138 | 6.1.3.3 | Investigational Medicinal Product Accountability | 6.1.3.3 Investigational Medicinal Product Accountability All IMP and any other study-related material is to be accounted for on the IMP accountability log provided by the sponsor. Any reconstituted unused IMP has to be inactivated using bleach and used/partly used vials should be destroyed after use at the site for saf... | [] |
NCT02660138 | 6.1.4 | Investigational Medicinal Product Packaging, Release, and Labelling | 6.1.4 Investigational Medicinal Product Packaging, Release, and Labelling The IMP will be packaged and released by Beaufour Ipsen Industrie (CMC SC) and delivered to the investigational sites or interim storage facilities. A sufficient quantity of IMP will be supplied as well as an acknowledgement of receipt form. The ... | [] |
NCT02660138 | 6.1.5 | Compliance | 6.1.5 Compliance The IMP will be administered periodically in the study by the investigator, thus, monitoring of subject compliance with IMP administration is not applicable. Drug accountability records, documenting that the subject received allocated IMP administration, will be maintained by the investigator. | [] |
NCT02660138 | 6.2 | Procedures Associated with Investigational Medicinal Product Administration | 6.2 Procedures Associated with Investigational Medicinal Product Administration | [] |
NCT02660138 | 6.2.1 | Antibiotic Prophylaxis | 6.2.1 Antibiotic Prophylaxis All subjects must receive appropriate prophylactic antibiotics CCI - Treatment 1: - antibiotics must be adapted based on screening culture and sensitivity. - Retreatments: - antibiotics may be empiric or adapted. See Section [6.4.1.2](#page-72-0) for full details on antibiotic prophylaxis w... | [] |
NCT02660138 | 6.2.2 | Anticoagulant/Antiplatelet Usage | 6.2.2 Anticoagulant/Antiplatelet Usage Medications with anticoagulant effects must be stopped at least 3 days prior to IMP administration and only restarted on the day following IMP administration. They may be stopped for a longer period if deemed necessary in the opinion of the investigator. These medications include ... | [] |
NCT02660138 | 6.2.3 | Anaesthesia | 6.2.3 Anaesthesia Local or general anaesthesia may be used if required. The choice of anaesthesia for the treatment procedure should be determined by the investigator and/or anaesthetist (anaesthesiologist) to ensure appropriate safety and comfort for the subject (taking into account factors such as risk of autonomic d... | [] |
NCT02660138 | 6.2.4 | Safety Monitoring During Treatment Administration | 6.2.4 Safety Monitoring During Treatment Administration Appropriate resuscitation equipment and trained personnel must be available at the site to treat any life-threatening emergencies (e.g. anaphylaxis, autonomic dysreflexia or cardiorespiratory arrest) during the IMP administration and during the immediate post-trea... | [] |
NCT02660138 | 6.3 | Intradetrusor Treatment Paradigm | 6.3 Intradetrusor Treatment Paradigm IMP administration must only be performed by the investigator(s) who is/are authorised to provide IMP administration in this study. The procedure should be performed with an appropriate assistant (e.g. subinvestigator, study co-ordinator or nurse). The entire procedure must be perfo... | [] |
NCT02660138 | 6.3.1 | Pretreatment Activities | 6.3.1 Pretreatment Activities Prior to commencing the procedure the investigator must confirm: - All pretreatment study visit procedures have been conducted - There are no symptoms suggestive of an active UTI on the day of treatment - The urine pregnancy test is negative (childbearing females only) - Appropriate prophy... | [] |
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