An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
NCT ID: NCT00601484
Last Updated: 2021-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2008-03-17
2009-04-15
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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1
PF-04383119
PF-04383119 200 mcg/kg IV, single dose
2
Placebo
placebo IV, single dose
Interventions
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PF-04383119
PF-04383119 200 mcg/kg IV, single dose
Placebo
placebo IV, single dose
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.
Exclusion Criteria
* History of recurrent urinary tract infections, or genitourinary cancer;
* History of hepatitis B, C or human immunodeficiency virus (HIV);
* 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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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pivotal Research Center
Peoria, Arizona, United States
Urology Associates of Central California
Fresno, California, United States
Citrus Valley Medical Research Inc.
Glendora, California, United States
SD Uro-Research
San Diego, California, United States
Boulder Medical Center
Boulder, Colorado, United States
Hartford Hospital, Urogynecology Division
Hartford, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
The Connecticut Clinical Research Center, Urology Specialists PC
Middlebury, Connecticut, United States
Waterbury Neurology
Middlebury, Connecticut, United States
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Timothy M. Barczak, MD, LLC
New London, Connecticut, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Metropolitan Urology
Jeffersonville, Indiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Michigan Institute of Urology
Troy, Michigan, United States
Michigan Institute of Urology
Utica, Michigan, United States
Barnes Jewish West County Hospital
St Louis, Missouri, United States
Washington University, Division of Urologic Surgery
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Quality Clinical Research Inc
Omaha, Nebraska, United States
The Arthur Smith Institute for Urology
New Hyde Park, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States
Tri-State Urologic Services PSC, Inc. dba The Urology Group
Cincinnati, Ohio, United States
Parkhurst Research Organization, LLC
Bethany, Oklahoma, United States
Triangle Urological Associates
Pittsburgh, Pennsylvania, United States
Matrix Research, LLC (Administrative Only)
Greer, South Carolina, United States
The Urology Group
Greer, South Carolina, United States
Mobley Research Center
Houston, Texas, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, United States
Northside Internal Medicine
Spokane, Washington, United States
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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IC POC
Identifier Type: OTHER
Identifier Source: secondary_id
A4091010
Identifier Type: -
Identifier Source: org_study_id
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