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.

NCT01458197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2014-03-12

No results posted yet for this study

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

Interventions

DRUG

Tarafenacin 0.2 mg

Capsule, qd, 12 weeks

DRUG

Placebo

Capsule, qd, 12 weeks

DRUG

Tarafenacin 0.4 mg

Capsule, qd, 12 weeks

Sponsors & Collaborators

  • Kwang Dong Pharmaceutical co., ltd.

    lead INDUSTRY

Principal Investigators

  • Myung-Soo Choo, Professor · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01458197 on ClinicalTrials.gov