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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: Comparator: Placebo to tolterodine tartrate; Drug: tolterodine tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768521

2008_560

0000-107

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups

1

Experimental group

Description:

Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo

Treatment:

Drug: Comparator: Placebo to tolterodine tartrate

Drug: tolterodine tartrate

2

Experimental group

Description:

Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)

Treatment:

Drug: Comparator: Placebo to tolterodine tartrate

Drug: tolterodine tartrate

3

Experimental group

Description:

Part II, Sequence 1: study drug crossing over to placebo

Treatment:

Drug: Comparator: Placebo to tolterodine tartrate

Drug: tolterodine tartrate

4

Experimental group

Description:

Part II, Sequence 2: placebo crossing over to study drug

Treatment:

Drug: Comparator: Placebo to tolterodine tartrate

Drug: tolterodine tartrate