An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
NCT ID: NCT00739739
Last Updated: 2011-03-28
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
161 participants
INTERVENTIONAL
2008-08-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PD 0299685 15mg
PD 0299685 at 15mg BID
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
PD 0299685 30mg
PD 0299685 at 30mg BID
10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
Placebo
placebo for PD 0299685
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Interventions
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PD 0299685 at 15mg BID
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
PD 0299685 at 30mg BID
10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
placebo for PD 0299685
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.
Exclusion Criteria
* History of current or recurrent urinary tract infections, or genitourinary cancer
* Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
* Use of certain drugs given into the bladder up to 1 month prior to study entry
18 Years
ALL
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
Mobile, Alabama, United States
Pfizer Investigational Site
Goodyear, Arizona, United States
Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Glendora, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Jeffersonville, Indiana, United States
Pfizer Investigational Site
Shreveport, Louisiana, United States
Pfizer Investigational Site
Brighton, Massachusetts, United States
Pfizer Investigational Site
Watertown, Massachusetts, United States
Pfizer Investigational Site
Garden City, New York, United States
Pfizer Investigational Site
Poughkeepsie, New York, United States
Pfizer Investigational Site
Burlington, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
West Chester, Ohio, United States
Pfizer Investigational Site
Bethany, Oklahoma, United States
Pfizer Investigational Site
State College, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Spokane, Washington, United States
Pfizer Investigational Site
Victoria, British Columbia, Canada
Pfizer Investigational Site
Barrie, Ontario, Canada
Pfizer Investigational Site
Kingston, Ontario, Canada
Pfizer Investigational Site
Kingston, Ontario, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Sherbrooke, Quebec, Canada
Pfizer Investigational Site
Herlev, , Denmark
Pfizer Investigational Site
Helsinki, , Finland
Pfizer Investigational Site
Kouvola, , Finland
Pfizer Investigational Site
OYS, , Finland
Pfizer Investigational Site
Seinäjoki, , Finland
Pfizer Investigational Site
Tampere, , Finland
Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Nantes, , France
Pfizer Investigational Site
Nîmes, , France
Pfizer Investigational Site
Paris, , France
Pfizer Investigational Site
Rennes, , France
Pfizer Investigational Site
Strasbourg, , France
Pfizer Investigational Site
Homburg, , Germany
Pfizer Investigational Site
München, , Germany
Countries
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References
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Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.
Other Identifiers
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A4291043
Identifier Type: -
Identifier Source: org_study_id
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