NCT00335660

Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Investigate the Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Avera Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.

Detailed description

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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	AV608

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-06-01
• Completion: 2007-09-01
• First posted: 2006-06-12
• Last updated: 2008-02-25

Locations

13 sites across 2 countries: Netherlands, United Kingdom