Trial intelligence / Profile preview

MATRIX: Oxytrol in Overactive Bladder

NCT00224146Phase 4

Key facts

Status: Completed
Start: May 2004
Primary completion: May 2005
Countries: 1
Sponsor: Watson Pharmaceuticals
Modality: Small Molecules

Drugs: oxybutynin
Conditions: overactive bladder (OAB)

Overview

Phase 4, randomised, open-label trial of oxybutynin in overactive bladder (OAB) (2 arms), sponsored by Watson Pharmaceuticals. Primary endpoint: Change in Health-Related Quality of Life at 6 months. Started May 2004; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Standard Education
Oxytrol + Standard Patient Education
Enhanced Education
Oxytrol + Enhanced Patient Education Materials

Who it enrols

Adult patients with one or more symptoms of overactive bladder (urge urinary incontinence, urgency, and/or frequency). Patients residing in long-term care facilities or those previously treated with Oxytrol are excluded.

Endpoints

Primary

Change in Health-Related Quality of Life6 months

Secondary

Change in Depression Symptoms6 months
Change in Work Productivity6 months
Participant Satisfaction6 months

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