Overview

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

Status:
Completed

Trial end date:
2006-11-01

Target enrollment:
0

Participant gender:
Female

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Pregabalin
Tolterodine Tartrate

Criteria

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.