Phase 1 N=20 Randomized Double-blind Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT00768521 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo — 1.15; 0.94 Percentage change — p=0.008

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: tolterodine tartrate (Drug); Comparator: Placebo to tolterodine tartrate (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo	1.15; 0.94	0.008 sig
SECONDARY Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo	0.92; 0.91	0.422

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00768521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.