Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
NCT ID: NCT00746681
Last Updated: 2009-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
188 participants
INTERVENTIONAL
2005-12-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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A
Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
Tolterodine & Pregabalin
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
B
Tolterodine SR 4 mg once daily
Tolterodine
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
C
Placebo
Placebo
Placebo, Oral, twice daily for 4 weeks
D
Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
Tolterodine & Pregabalin
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
E
Pregabalin 150 mg twice daily
Pregabalin
Pregabalin, Oral, 150 mg twice daily for 4 weeks
Interventions
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Tolterodine & Pregabalin
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
Tolterodine
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
Placebo
Placebo, Oral, twice daily for 4 weeks
Tolterodine & Pregabalin
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
Pregabalin
Pregabalin, Oral, 150 mg twice daily for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week)
Exclusion Criteria
* Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
* Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Hradec Králové, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Prague, , Czechia
Pfizer Investigational Site
Praha 4 - Krc, , Czechia
Pfizer Investigational Site
Ústí nad Labem, , Czechia
Pfizer Investigational Site
Kaunas, , Lithuania
Pfizer Investigational Site
Kaunas, , Lithuania
Pfizer Investigational Site
Vilnius, , Lithuania
Pfizer Investigational Site
Vilnius, , Lithuania
Pfizer Investigational Site
Haugesund, , Norway
Pfizer Investigational Site
Moelv, , Norway
Pfizer Investigational Site
Trondheim, , Norway
Pfizer Investigational Site
Martin, Slovakia, Slovakia
Pfizer Investigational Site
Bratislava, , Slovakia
Pfizer Investigational Site
Košice, , Slovakia
Pfizer Investigational Site
Skalica, , Slovakia
Pfizer Investigational Site
Luleå, , Sweden
Pfizer Investigational Site
Norrköping, , Sweden
Pfizer Investigational Site
Stockholm, , Sweden
Pfizer Investigational Site
Dundee, Tayside, United Kingdom
Pfizer Investigational Site
Bristol, , United Kingdom
Pfizer Investigational Site
Dundee, , United Kingdom
Pfizer Investigational Site
Plymouth, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8881001
Identifier Type: -
Identifier Source: org_study_id