A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

Phase 1 Completed 20 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindTreatment

Summary

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Timeline

Start: 2008-09-03
Primary completion: 2009-01-19
Completion: 2009-01-19

Outcome

Met primary endpoint

registry Tolterodine vs Placebo; p = 0.008; Mean Difference (Final Values) 23.18 (90% CI 7.58 to 41.06) NCT00768521 ↗

paper for tolterodine compared with placebo was 28.9% (P = 0.038, one-sided) PMID 21905086 ↗

Publications

Frenkl T, Railkar R, Shore N, Bailen J, Sutherland S, Burke J, Scott BB, Ruddy M, Beals C. Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder. Neurourol Urodyn. 2012 Jan;31(1):69-74. doi: 10.1002/nau.21094. Epub 2011 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tolterodine	Unknown	4 mg	—