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

This study has been completed.
Sponsor:
Information provided by:
FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier:
NCT00749632
First received: September 5, 2008
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Urinary Incontinence, Urge
Drug: oxybutynin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by FemmePharma Global Healthcare, Inc.:

Primary Outcome Measures:
  • Number of micturations and incontinence episodes. [ Time Frame: Two weeks pretreatment and three weeks on treatment ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  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: NCT00749632

Locations
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
Study Director: Peter K. Mays, Ph.D. FemmePharma Global Healthcare, Inc.
  More Information

No publications provided

Responsible Party: Peter K. Mays, Ph.D. / V.P. Pharmaceutical Development, FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00749632     History of Changes
Other Study ID Numbers: FP1097-002
Study First Received: September 5, 2008
Last Updated: October 13, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by FemmePharma Global Healthcare, Inc.:
urinary incontinence, urge
urinary urge incontinence
urge incontinence
over active bladder

Additional relevant MeSH terms:
Urinary Incontinence
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 July 26, 2014