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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768521
• Other study ID #: 0000-107
• Secondary ID: 2008_560
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2008
• Last updated: January 24, 2018
• Start date: September 3, 2008
• Est. completion date: January 19, 2009

Study information

• Verified date: January 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 19, 2009
• Est. primary completion date: January 19, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• tolterodine tartrate
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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo	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)	4 hours post dose 7
Secondary	Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo	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)	4 hours post dose 1