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A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence (FP1097-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00749632
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : October 15, 2009
Sponsor:
Information provided by:
FemmePharma Global Healthcare, Inc.

Brief Summary:
The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Condition or disease Intervention/treatment Phase
Urinary Incontinence, Urge Drug: oxybutynin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence
Study Start Date : July 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 Drug: oxybutynin
low dose oxybutynin administered daily

Active Comparator: 2 Drug: oxybutynin
middle dose oxybutynin administered daily

Active Comparator: 3 Drug: oxybutynin
high dose oxybutynin administered daily




Primary Outcome Measures :
  1. Number of micturations and incontinence episodes. [ Time Frame: Two weeks pretreatment and three weeks on treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females 18 to 75 years of age
  • Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion Criteria:

  • Is pregnant or lactating
  • Has had lower urinary tract surgery within 6 months prior to Screening
  • Has a history of urinary retention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749632


Locations
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United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
United States, New Jersey
Advanced Biomedical Research
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
FemmePharma Global Healthcare, Inc.
Investigators
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Study Director: Peter K. Mays, Ph.D. FemmePharma Global Healthcare, Inc.
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Responsible Party: Peter K. Mays, Ph.D. / V.P. Pharmaceutical Development, FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00749632    
Other Study ID Numbers: FP1097-002
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009
Keywords provided by FemmePharma Global Healthcare, Inc.:
urinary incontinence, urge
urinary urge incontinence
urge incontinence
over active bladder
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mandelic Acids
Oxybutynin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents