CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 345 enrolled
Drug / intervention
Oxybutynin chloride OROSdrug
Likely dose
Oxybutynin chloride OROS 10 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00613327
NCT00613327Phase 4Completed
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The Efficacy of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients

Janssen Korea, Ltd., Korea·interventional·Posted Feb 13, 2008·Updated Nov 19, 2013

In Brief

A Phase 4 clinical trial evaluating Oxybutynin chloride OROS for Urinary Bladder, Overactive. Completed, enrolled 345 participants.

Detailed Summary

The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Bladder, Overactive
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2008
Enrollment StartSep 1, 2007
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.4 years ago

Interventions

Oxybutynin chloride OROSdrug

Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.