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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

July 1, 2009
December 14, 2012
July 2009
December 2011   (final data collection date for primary outcome measure)
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.
Median % change from baseline in the Urinary Urgency Incontinence [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00932022 on ClinicalTrials.gov Archive Site
  • 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.
  • Mean % change from baseline in urgency severity associated with toilet voids [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Mean % change from baseline in voided volume [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Mean % change from baseline in OAB-Symptom Composite Score [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Mean % change from baseline in percentage of patients continent [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trospium Chloride XR in Obese Female Patients With Overactive Bladder
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Overactive Bladder
  • Incontinence
  • 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.
  • 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.
    Interventions:
    • Drug: Trospium Chloride, Extended Release (XR)
    • Other: placebo
  • Placebo Comparator: placebo
    Placebo capsule taken orally once daily for 14 weeks.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932022
MA-SXR-09-003, Sanctura XR obesity OAB Trial
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP