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Trospium Chloride XR in Obese Female Patients With Overactive Bladder

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ClinicalTrials.gov Identifier: NCT00932022
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Overactive Bladder Incontinence Drug: Trospium Chloride, Extended Release (XR) Other: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Percent Change From Baseline in Urinary Urgency Incontinence (UUI) [ Time Frame: Baseline (Week 2), Week 14 ]
    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 :
  1. Percent Change From Baseline in Urgency Severity Associated With Toilet Voids [ Time Frame: Baseline (Week 2), Week 14 ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  2. Percent Change From Baseline in Voided Volume [ Time Frame: Baseline (Week 2), Week 14 ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  3. Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score [ Time Frame: Baseline (Week 2), Week 14 ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  4. Percent Change From Baseline in Percentage of Patients Continent [ Time Frame: Baseline (Week 2), Week 14 ]
    Due to lack of evaluable data, analysis for this outcome measure was not performed.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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

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): NCT00932022


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00932022     History of Changes
Other Study ID Numbers: MA-SXR-09-003
Sanctura XR obesity OAB Trial ( Other Identifier: Allergan )
First Posted: July 2, 2009    Key Record Dates
Results First Posted: January 21, 2013
Last Update Posted: January 21, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Trospium chloride
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