A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00768521
First received: October 7, 2008
Last updated: November 10, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: tolterodine tartrate
Drug: Comparator: Placebo to tolterodine tartrate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Comparison of maximum cystometric capacity at steady state after treatment with study drug or placebo [ Time Frame: 4 hours post dose 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of maximum cystometric capacity 4 hours post dose of study drug vs. placebo [ Time Frame: 4 hours post dose 1 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo
Drug: tolterodine tartrate
Part I: tolterodine tartrate 4mg capsule qd for 7 days Part IIa: tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4mg capsule
Drug: Comparator: Placebo to tolterodine tartrate
Part I: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIa: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4mg capsule
Experimental: 2
Part I, Sequence 2: placebo crossing over to study drug 4mg qd
Drug: tolterodine tartrate
Part I: tolterodine tartrate 4mg capsule qd for 7 days Part IIa: tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4mg capsule
Drug: Comparator: Placebo to tolterodine tartrate
Part I: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIa: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4mg capsule
Experimental: 3
Part II, Sequence 1: study drug crossing over to placebo
Drug: tolterodine tartrate
Part I: tolterodine tartrate 4mg capsule qd for 7 days Part IIa: tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4mg capsule
Drug: Comparator: Placebo to tolterodine tartrate
Part I: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIa: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4mg capsule
Experimental: 4
Part II, Sequence 2: placebo crossing over to study drug
Drug: tolterodine tartrate
Part I: tolterodine tartrate 4mg capsule qd for 7 days Part IIa: tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4mg capsule
Drug: Comparator: Placebo to tolterodine tartrate
Part I: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIa: placebo to tolterodine tartrate 4mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4mg capsule

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is a postmenopausal female 40 to 75 years of age
  • Patient has a 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768521

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00768521     History of Changes
Other Study ID Numbers: 2008_560, 107
Study First Received: October 7, 2008
Last Updated: November 10, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Phenylpropanolamine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 15, 2014