A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00768521
First received: October 7, 2008
Last updated: November 10, 2009
Last verified: November 2009
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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:
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
More Information
No publications provided by Merck
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 May 19, 2013