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

• Status: Terminated
• Trial end date: 2014-05-14
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Afferent Pharmaceuticals, Inc.

Criteria

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