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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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    October 7, 2008
    Last Updated
    January 24, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    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

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

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