Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
NCT00746681
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Women > 18 years Old
- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
- Subjects with symptoms of overactive bladder for less than 6 months prior to
randomization.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Québec City, Quebec
- Seoul,
- Daegu,
- Changwon,
- Seoul,
- Bucheon,
- Seoul,
- Bucheon,
- Seoul,
- Seoul,
- Pusan,
- Gwangju,
- Deajeon,
- Seoul,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder | |||
Official Title ICMJE | A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder | |||
Brief Summary | Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Overactive Bladder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 188 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Czech Republic, Lithuania, Norway, Slovakia, Sweden, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00746681 | |||
Other Study ID Numbers ICMJE | A8881001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |