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

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

Status and phase: Terminated; Phase 2

Conditions: Bladder Pain Syndrome

Treatments: Drug: Placebo; Drug: Gefapixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569438

MK-7264-005 (Other Identifier)

7264-005

AF219-005 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of gefapixant in female participants with moderate to severe pain associated with IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.

Enrollment: 107 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups, including a placebo group

Gefapixant

Experimental group

Description:

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.

Treatment:

Drug: Gefapixant

Placebo

Placebo Comparator group

Description:

Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.

Treatment:

Drug: Placebo