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OpenTrials
Completed

NCT Number: NCT00768521

A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is a postmenopausal female 40 to 75 years of age
  • Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
  • Patient has a documented history of overactive bladder for at least 6 months prior to screening

Exclusion criteria

  • Patient has stress or mixed incontinence
  • Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
  • Patient has a history of stroke, seizures, or major neurological disorders
  • Patient has a history of fecal incontinence
  • Patient has a history of continual urine leakage
  • Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start
  • Patient received bladder training of electrostimulation within 2 weeks of study start
  • Patient requires a catheter
  • Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
  • Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
  • Patient has been on hormone replacement therapy for less than 12 weeks at study start
  • Patient must take medication for arrhythmia
  • Patient consumes more than 2 alcoholic beverages per day
  • Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)
  • Patient has multiple and/or severe allergies to foods and drugs
  • Patient regularly uses any illegal drugs

Treatment and study plan

tolterodine tartrate

Drug

Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule

Comparator: Placebo to tolterodine tartrate

Drug

Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Primary outcomes

  1. Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo

    Time frame: 4 hours post dose 7

    Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

Secondary outcomes

  1. Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo

    Time frame: 4 hours post dose 1

    Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Feb 22, 2018

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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