Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antares Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00909181
First received: May 25, 2009
Last updated: June 23, 2014
Last verified: June 2014
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Polyuria
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Lower Urinary Tract 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
Urological Agents
Therapeutic Uses
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents

ClinicalTrials.gov processed this record on August 01, 2014