NCT01868516

Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,635 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

Detailed description

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	dexmecamylamine
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-06-04
• Last updated: 2015-06-03

Locations

125 sites across 1 country: United States