drugset

drugset / Trial / NCT00168454

A Research Study for Patients With Overactive Bladder

NCT00168454 ↗

Phase 2 Completed 313 enrolled Allergan

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Timeline

Start: 2005-07
Primary completion: 2008-01
Completion: 2008-06

Publications

Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	50 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	150 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Other
Subject	Botulinum toxin type A	Protein / enzyme biologic	300 iu	Other

Indications