Status:
COMPLETED
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Overactive Bladder
Eligibility:
FEMALE
40-75 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00768521
Start Date
September 3 2008
End Date
January 19 2009
Last Update
February 22 2018
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