TerminatedPhase 2

The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)

United States107 participantsStarted 2012-04-13

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT01569438

SponsorAfferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05-01

Results submitted2016-09-23

View on ClinicalTrials.gov More Bladder Pain Syndrome trials