The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Bladder Pain Syndrome
In brief
The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.
Key facts
- Study ID
- NCT01569438
- Run by
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 107
- Starts
- 2012-04-13
- Expected to finish
- 2014-05-14
- Last updated by the study team
- 2020-08-17
Who can join
Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women
- 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
You may not qualify if…
- History of diseases that can be confused for IC/BPS
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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