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Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

NCT00196404 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2012-08-20

No results posted yet for this study

Summary

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Conditions

Interventions

DRUG

DR-3001a

4mg daily vaginally

DRUG

DR-3001b

6 mg vaginally daily

OTHER

Placebo

Administered vaginally to match experimental arms

Sponsors & Collaborators

  • Duramed Research

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Duramed Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00196404 on ClinicalTrials.gov