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Trospium Chloride XR in Obese Female Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00932022
First received: July 1, 2009
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.


Condition Intervention Phase
Obesity
Overactive Bladder
Incontinence
 Drug: Trospium Chloride, Extended Release (XR)
Other: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percent Change From Baseline in Urinary Urgency Incontinence (UUI) [ Time Frame: Baseline (Week 2), Week 14 ] [ Designated as safety issue: No ]
    Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.


Secondary Outcome Measures:
  • Percent Change From Baseline in Urgency Severity Associated With Toilet Voids [ Time Frame: Baseline (Week 2), Week 14 ] [ Designated as safety issue: No ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  • Percent Change From Baseline in Voided Volume [ Time Frame: Baseline (Week 2), Week 14 ] [ Designated as safety issue: No ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  • Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score [ Time Frame: Baseline (Week 2), Week 14 ] [ Designated as safety issue: No ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  • Percent Change From Baseline in Percentage of Patients Continent [ Time Frame: Baseline (Week 2), Week 14 ] [ Designated as safety issue: No ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.


Enrollment: 127
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trospium chloride XR 60 mg
Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
 Drug: Trospium Chloride, Extended Release (XR)
Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.
Other Name: Sanctura XR™ 60 mg
Other: placebo
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
Placebo Comparator: placebo
Placebo capsule taken orally once daily for 14 weeks.
 Other: placebo
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
  • Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
  • Obese

Exclusion Criteria:

  • Chronic kidney failure
  • Abdominal bypass surgery for obesity
  • Moderate or severe memory impairment
  • Uncontrolled narrow angle glaucoma
  • Uncontrolled systemic disease
  • Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932022

Locations
United States, California
La Mesa, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932022     History of Changes
Other Study ID Numbers: MA-SXR-09-003, Sanctura XR obesity OAB Trial
Study First Received: July 1, 2009
Results First Received: December 14, 2012
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Urinary Bladder, Overactive
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
 Trospium chloride
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013