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

Allergan

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Drug: placebo; Drug: trospium chloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01089751

GMA-SXR-09-004

Details and patient eligibility

About

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.

Enrollment: 322 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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322 participants in 2 patient groups, including a placebo group

Sanctura XR®

Experimental group

Description:

Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.

Treatment:

Drug: trospium chloride

Placebo

Placebo Comparator group

Description:

Placebo once daily on an empty stomach for 14 weeks.

Treatment:

Drug: placebo