Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence - Full Text View

Sponsor:	Antares Pharma Inc.
Information provided by:	Antares Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00909181

Purpose

The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.

The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.

Condition	Intervention	Phase
Urge Urinary Incontinence Urinary Frequency	Drug: Oxybutynin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Parallel, Placebo-Controlled, Multicenter Study Evaluating the Effect of Treatment With Topically Administered Oxybutynin Gel in Patients With Urinary Frequency, and Urge and Mixed Urinary Incontinence With a Predominance of Urge Incontinence Episodes With an Open-Label Extension

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Oxybutynin chloride Oxybutynin

U.S. FDA Resources

Further study details as provided by Antares Pharma Inc.:

Primary Outcome Measures:

Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.

Enrollment:	626
Study Start Date:	March 2009
Study Completion Date:	November 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Oxybutynin Gel 56 mg/day	Drug: Oxybutynin Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3% Drug: Placebo Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3%
Experimental: Oxybutynin Gel 84 mg/day	Drug: Oxybutynin Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3% Drug: Placebo Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3%
Placebo Comparator: Placebo Gel	Drug: Oxybutynin Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3% Drug: Placebo Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo Other Name: Anturol; Oxybutynin Gel 3%

Eligibility

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

Criteria

Inclusion Criteria:

Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months
Have a history of at least 1 - 2 urge episodes and 8 or more voids per day

Exclusion Criteria:

Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications
PVR volume > 200 mL or relative PVR > 50% of pre-void volume as determined by bladder ultrasound
History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909181

Show 55 Study Locations

Sponsors and Collaborators

Antares Pharma Inc.

More Information

No publications provided

Responsible Party:	Kaushik Dave, SVP Product Development, Antares Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00909181 History of Changes
Other Study ID Numbers:	20070060
Study First Received:	May 25, 2009
Results First Received:	November 29, 2010
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Polyuria
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Oxybutynin
Mandelic Acids
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
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012