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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00768521
First received: October 7, 2008
Last updated: August 1, 2014
Last verified: August 2014

October 7, 2008
August 1, 2014
September 2008
January 2009   (final data collection date for primary outcome measure)
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo [ Time Frame: 4 hours post dose 7 ] [ Designated as safety issue: No ]
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)
Comparison of maximum cystometric capacity at steady state after treatment with study drug or placebo [ Time Frame: following dose 7 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768521 on ClinicalTrials.gov Archive Site
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo [ Time Frame: 4 hours post dose 1 ] [ Designated as safety issue: No ]
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)
Comparison of maximum cystometric capacity 4 hours post dose of study drug vs. placebo [ Time Frame: 4 hours post doses 1 and 7 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • 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

  • Drug: 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

  • Experimental: 1
    Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
    Interventions:
    • Drug: tolterodine tartrate
    • Drug: Comparator: Placebo to tolterodine tartrate
  • Experimental: 2
    Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
    Interventions:
    • Drug: tolterodine tartrate
    • Drug: Comparator: Placebo to tolterodine tartrate
  • Experimental: 3
    Part II, Sequence 1: study drug crossing over to placebo
    Interventions:
    • Drug: tolterodine tartrate
    • Drug: Comparator: Placebo to tolterodine tartrate
  • Experimental: 4
    Part II, Sequence 2: placebo crossing over to study drug
    Interventions:
    • Drug: tolterodine tartrate
    • Drug: Comparator: Placebo to tolterodine tartrate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Female
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00768521
0000-107, 2008_560
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP