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OpenTrials
Completed

NCT Number: NCT00746681

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tolterodine & Pregabalin

Drug

Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks

tolterodine

Drug

Tolterodine SR, Oral, 4 mg, once daily for 4 weeks

Placebo

Drug

Placebo, Oral, twice daily for 4 weeks

Pregabalin

Drug

Pregabalin, Oral, 150 mg twice daily for 4 weeks

Primary outcomes

  1. Change in mean voided volume per micturition (from baseline).

    Time frame: 4 weeks

Secondary outcomes

  1. Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).

    Time frame: 4 Weeks

  2. Percentage and absolute change in urgency episode frequency

    Time frame: 4 Weeks

  3. Mean severity of urgency episodes

    Time frame: 4 Weeks

  4. Percentage and absolute change in micturition frequency

    Time frame: 4 Weeks

  5. Percentage and absolute change in normalized micturition frequency (NMF)

    Time frame: 4 Weeks

  6. Patient perception of their urinary urgency (using the OAB-q symptom severity scale)

    Time frame: 4 Weeks

  7. Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)

    Time frame: 4 Weeks

  8. Patient Perception of Bladder Condition (PPBC) scale

    Time frame: 4 Weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder

Important dates

Study start
2005
Study completion
2006
First posted
Sep 4, 2008
Registry last updated
Dec 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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