The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
NCT ID: NCT01569438
Last Updated: 2020-08-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
107 participants
INTERVENTIONAL
2012-04-13
2014-05-14
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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Gefapixant
Female participants receive gefapixant, a total dose titrated from 50 mg to highest tolerated dose (maximum of 300 mg) twice daily (BID), orally over a period of 6 days with food depending on safety and tolerability, and then maintain that dose for the course of a 4-week treatment period. Participants were allowed to decrease the dose if tolerability issues occurred.
Gefapixant
50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks
Placebo
Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
Placebo
Dose matched placebo tablets, BID, orally, with food for 4 weeks
Interventions
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Gefapixant
50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks
Placebo
Dose matched placebo tablets, BID, orally, with food for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Clinical evidence of Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)
* Have provided written informed consent
Exclusion Criteria
* Unable to void spontaneously
* Immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain periods prior to start of the study
* Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1 antagonist, or anti-muscarinic treatment within a certain period prior to the start of the study
18 Years
80 Years
FEMALE
No
Sponsors
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Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Locations
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Afferent Investigative Site
Glendale, Alabama, United States
Afferent Investigative Site
Homewood, Alabama, United States
Afferent Investigative Site
Mobile, Alabama, United States
Afferent Investigative Site
Phoenix, Arizona, United States
Afferent Investigative Site
Glendora, California, United States
Afferent Investigative Site
Murrieta, California, United States
Afferent Investigative Site
San Diego, California, United States
Afferent Investigative Site
San Diego, California, United States
Afferent Investigative Site
Farmington, Connecticut, United States
Afferent Investigative Site
New Britain, Connecticut, United States
Afferent Investigative Site
Boynton Beach, Florida, United States
Afferent Investigative Site
Plantation, Florida, United States
Afferent Investigative Site
Coeur d'Alene, Idaho, United States
Afferent Investigative Site
Idaho Falls, Idaho, United States
Afferent Investigative Site
Meridian, Idaho, United States
Afferent Investigative Site
Shreveport, Louisiana, United States
Afferent Investigative Site
Annapolis, Maryland, United States
Afferent Investigative Site
Ann Arbor, Michigan, United States
Afferent Investigative Site
Grand Rapids, Michigan, United States
Afferent Investigative Site
Kalamazoo, Michigan, United States
Afferent Investigative Site
Royal Oak, Michigan, United States
Afferent Investigative Site
Voorhees Township, New Jersey, United States
Afferent Investigative Site
Albuquerque, New Mexico, United States
Afferent Investigative Site
Brooklyn, New York, United States
Afferent Investigative Site
Hyde Park, New York, United States
Afferent Investigative Site
Greenville, North Carolina, United States
Afferent Investigative Site
Salisbury, North Carolina, United States
Afferent Investigative Site
Winston-Salem, North Carolina, United States
Afferent Investigative Site
Cincinnati, Ohio, United States
Afferent Investigative Site
Cleveland, Ohio, United States
Afferent Investigative Site
Tiffin, Ohio, United States
Afferent Investigative Site
Zanesville, Ohio, United States
Afferent Investigative Site
Bala-Cynwyd, Pennsylvania, United States
Afferent Investigative Site
Lancaster, Pennsylvania, United States
Afferent Investigative Site
Myrtle Beach, South Carolina, United States
Afferent Investigative Site
Dallas, Texas, United States
Afferent Investigative Site
Fort Worth, Texas, United States
Afferent Investigative Site
Houston, Texas, United States
Afferent Investigative Site
Irving, Texas, United States
Afferent Investigative Site
Salt Lake City, Utah, United States
Afferent Investigative Site
Virginia Beach, Virginia, 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.
Other Identifiers
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AF219-005
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7264-005
Identifier Type: OTHER
Identifier Source: secondary_id
7264-005
Identifier Type: -
Identifier Source: org_study_id
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