|
|
|
|
|
|
Sponsored by: |
Avera Pharmaceuticals |
Information provided by: | Avera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00335660 |
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.
Condition | Intervention | Phase |
Overactive Bladder Syndrome |
Drug: AV608 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity |
Estimated Enrollment: | 62 |
Study Start Date: | June 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial.
Eligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |||||
Amsterdam, Netherlands | |||||
Zeist, Netherlands | |||||
Nieuwegein, Netherlands | |||||
United Kingdom, England | |||||
Plymouth, England, United Kingdom | |||||
Hull, England, United Kingdom | |||||
Blackburn, England, United Kingdom | |||||
London, England, United Kingdom | |||||
Leeds, England, United Kingdom | |||||
Liverpool, England, United Kingdom | |||||
Birmingham, England, United Kingdom | |||||
Chertsey, England, United Kingdom | |||||
Sheffield, England, United Kingdom | |||||
United Kingdom, Scotland | |||||
Falkirk, Scotland, United Kingdom |
Avera Pharmaceuticals |
Principal Investigator: | Linda Cardozo, MD FRCOG | King's College Hospital |
Study Director: | Joao Siffert, MD | Avera Pharmaceuticals, Inc. |
Study ID Numbers: | AV608-106 |
First Received: | June 8, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00335660 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
|
|
|