NCT01458197

A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.

A Prospective, Multi-center, Placebo-controlled, Randomized, Double-blind, Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo Administered as Oral Daily Dose for Three Months in Patients Suffering From Overactive Bladder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Kwang Dong Pharmaceutical co., ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1. Primary Objective: To evaluate the dose-response relationship of tarafenacin on efficacy. 2. Secondary Objectives: * To compare 12 weeks' efficacy of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. . * To compare the tolerability of different doses of tarafenacin to that of placebo in patients suffering from Overactive Bladder. .

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Tarafenacin 0.2 mg	Capsule, qd, 12 weeks
DRUG	Placebo	Capsule, qd, 12 weeks
DRUG	Tarafenacin 0.4 mg	Capsule, qd, 12 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2011-10-24
• Last updated: 2014-03-12

Locations

1 site across 1 country: South Korea