Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily

Study Identifier
GMA-SXR-09-004
CT.gov Identifier
NCT01089751
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Bladder Disorder - Overactive Bladder
    • Study Drug
  • trospium chloride
  • placebo
    • Phase
    Phase 4
    Sex
    Female
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification * Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence * Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).
    Exclusion Criteria:
    * Predominant stress or insensate incontinence * History of neurogenic bladder * Two urinary tract infections in the last six months * Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed) * Donated \>500mL blood in the 30 days prior to the screening visit

    Protocol Summary

    This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.

    Study Locations

    Location
    Status
    Location
    La Mesa, California, United States
    Status
    Not applicable