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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

Intervention: tolterodine tartrate (Drug); Comparator: Placebo to tolterodine tartrate (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo

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

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: September 2008
Last updated: July 22, 2015

Page last updated: August 23, 2015

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