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

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01089751

Run by

Allergan

People needed

322

Starts

2010-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-09-26

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Study site — La Mesa, California, United States

Full record on ClinicalTrials.gov

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