A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
tolterodine tartrate
Comparator: Placebo to tolterodine tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
Part II, Sequence 1: study drug crossing over to placebo
Part II, Sequence 2: placebo crossing over to study drug
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00768521
First Posted
October 7, 2008
Last Updated
January 24, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00768521
Brief Title
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Official Title
A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2008 (Actual)
Primary Completion Date
January 19, 2009 (Actual)
Study Completion Date
January 19, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
Arm Title
3
Arm Type
Experimental
Arm Description
Part II, Sequence 1: study drug crossing over to placebo
Arm Title
4
Arm Type
Experimental
Arm Description
Part II, Sequence 2: placebo crossing over to study drug
Intervention Type
Drug
Intervention Name(s)
tolterodine tartrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo to tolterodine tartrate
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
Description
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)
Time Frame
4 hours post dose 7
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
Description
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)
Time Frame
4 hours post dose 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21905086
Citation
Frenkl T, Railkar R, Shore N, Bailen J, Sutherland S, Burke J, Scott BB, Ruddy M, Beals C. Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder. Neurourol Urodyn. 2012 Jan;31(1):69-74. doi: 10.1002/nau.21094. Epub 2011 Sep 8.
Results Reference
derived
Learn more about this trial
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
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