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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00768521
Other study ID # 0000-107
Secondary ID 2008_560
Status Completed
Phase Phase 1
First received October 7, 2008
Last updated January 24, 2018
Start date September 3, 2008
Est. completion date January 19, 2009

Study information

Verified date January 2018
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 19, 2009
Est. primary completion date January 19, 2009
Accepts healthy volunteers No
Gender Female
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tolterodine tartrate
Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule
Comparator: Placebo to tolterodine tartrate
Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo 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) 4 hours post dose 7
Secondary Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data) 4 hours post dose 1
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