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Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients

NCT00730535 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2019-12-02

No results posted yet for this study

Summary

This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month.

Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.

Conditions

Interventions

DRUG

Tolterodine

Extended release tolterodine tartrate 4 mg, once daily, for 1 months

DRUG

Tolterodine

Extended release tolterodine tartrate 4 mg, once daily, for 3 months

DRUG

Tolterodine 6

Extended release tolterodine tartrate 4 mg, once daily, for 6 months

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • KYU-SUNG LEE

    lead OTHER

Principal Investigators

  • Kyu-Sung Lee, Ph.D · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00730535 on ClinicalTrials.gov