A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 20
- Primary Endpoint
- Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
Intervention: tolterodine tartrate (Drug)
2
Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
Intervention: tolterodine tartrate (Drug)
3
Part II, Sequence 1: study drug crossing over to placebo
Intervention: tolterodine tartrate (Drug)
4
Part II, Sequence 2: placebo crossing over to study drug
Intervention: tolterodine tartrate (Drug)
Outcomes
Primary Outcomes
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
- Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo(4 hours post dose 1)