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Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder (MATRIX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224146
First received: September 14, 2005
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)


Condition Intervention Phase
Overactive Bladder
Urinary Incontinence
Quality of Life
 Drug: oxybutynin transdermal delivery system (Oxytrol(r))
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Change in health-related quality of life [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in other outcomes such as: [ Designated as safety issue: No ]
  • depression [ Designated as safety issue: No ]
  • work productivity [ Designated as safety issue: No ]
  • participant satisfaction [ Designated as safety issue: No ]
  • effect of enhanced patient education on any of the above outcomes [ Designated as safety issue: No ]

Enrollment: 2878
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency

Exclusion Criteria:

  • Patients for whom Oxytrol(r) is contraindicated.
  • Patients treated with Oxytrol(r) prior to participation in this study.
  • Patients residing in long-term care facilities or nursing homes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224146

Locations
United States, Alabama
Mobile, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Torrance, California, United States
United States, Connecticut
Rocky Hill, Connecticut, United States
United States, Georgia
Valdosta, Georgia, United States
United States, Louisiana
Gretna, Louisiana, United States
United States, Michigan
Bloomfield Hills, Michigan, United States
United States, New York
Poughkeepsie, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Texas
Tomball, Texas, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Naomi V. Dahl, PharmD Watson Laboratories, Inc.
  More Information

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224146     History of Changes
Other Study ID Numbers: OXY0402, MATRIX
Study First Received: September 14, 2005
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Oxytrol(r)
transdermal oxybutynin
overactive bladder

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Oxybutynin
Parasympatholytics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013