Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

Pfizer

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: Pregabalin; Drug: Tolterodine & Pregabalin; Drug: Placebo; Drug: Tolterodine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746681

A8881001

Details and patient eligibility

About

Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.

Enrollment: 188 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women > 18 years Old
• Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)

Exclusion criteria

• Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
• Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
• Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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188 participants in 5 patient groups, including a placebo group

A

Experimental group

Description:

Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily

Treatment:

Drug: Tolterodine & Pregabalin

Drug: Tolterodine & Pregabalin

B

Active Comparator group

Description:

Tolterodine SR 4 mg once daily

Treatment:

Drug: Tolterodine

C

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

D

Experimental group

Description:

Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily

Treatment:

Drug: Tolterodine & Pregabalin

Drug: Tolterodine & Pregabalin

E

Experimental group

Description:

Pregabalin 150 mg twice daily

Treatment:

Drug: Pregabalin