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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
  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:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 20
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 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: 2
Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
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: 3
Part II, Sequence 1: study drug crossing over to placebo
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: 4
Part II, Sequence 2: placebo crossing over to study drug
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


  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00768521     History of Changes
Other Study ID Numbers: 0000-107, 2008_560
Study First Received: October 7, 2008
Results First Received: August 1, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014