The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
3 other identifiers
interventional
107
1 country
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2012
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedStudy Start
First participant enrolled
April 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2014
CompletedResults Posted
Study results publicly available
January 12, 2017
CompletedAugust 17, 2020
August 1, 2020
2 years
March 30, 2012
September 23, 2016
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4
The bladder pain severity was measured using 0-10 NPRS, with 0 representing 'no pain' and 10 representing 'the worst pain possible'. Participants were asked to select a number on the scale that best described the severity of bladder pain during past 24 hours over telephone using an interactive voice response system (IVRS) every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The primary analysis was conducted using a Mixed Model with Repeated Measures (MMRM) approach to calculate the Least Squares (LS) mean change from baseline in NPRS score and associated Standard Error (SE) at Week 4 for each treatment arm. Negative values indicate decrease in bladder pain severity.
Baseline and Week 4
Secondary Outcomes (3)
Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4
Baseline and Week 4
Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4
Baseline and Week 4
Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4
Baseline and Week 4
Study Arms (2)
Gefapixant
EXPERIMENTALFemale 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.
Placebo
PLACEBO COMPARATORFemale participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
Interventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Afferent Investigative Site
Glendale, Alabama, 85306, United States
Afferent Investigative Site
Homewood, Alabama, 35209, United States
Afferent Investigative Site
Mobile, Alabama, 36608, United States
Afferent Investigative Site
Phoenix, Arizona, 85018, United States
Afferent Investigative Site
Glendora, California, 91741, United States
Afferent Investigative Site
Murrieta, California, 91741, United States
Afferent Investigative Site
San Diego, California, 92120, United States
Afferent Investigative Site
San Diego, California, 92123, United States
Afferent Investigative Site
Farmington, Connecticut, 06032, United States
Afferent Investigative Site
New Britain, Connecticut, 06052, United States
Afferent Investigative Site
Boynton Beach, Florida, 33472, United States
Afferent Investigative Site
Plantation, Florida, 33317, United States
Afferent Investigative Site
Coeur d'Alene, Idaho, 83814, United States
Afferent Investigative Site
Idaho Falls, Idaho, 83404, United States
Afferent Investigative Site
Meridian, Idaho, 83642, United States
Afferent Investigative Site
Shreveport, Louisiana, 71106, United States
Afferent Investigative Site
Annapolis, Maryland, 21401, United States
Afferent Investigative Site
Ann Arbor, Michigan, 48109, United States
Afferent Investigative Site
Grand Rapids, Michigan, 49503, United States
Afferent Investigative Site
Kalamazoo, Michigan, 49009, United States
Afferent Investigative Site
Royal Oak, Michigan, 48073, United States
Afferent Investigative Site
Voorhees Township, New Jersey, 08043, United States
Afferent Investigative Site
Albuquerque, New Mexico, 87109, United States
Afferent Investigative Site
Brooklyn, New York, 11215, United States
Afferent Investigative Site
Hyde Park, New York, 11040, United States
Afferent Investigative Site
Greenville, North Carolina, 27834, United States
Afferent Investigative Site
Salisbury, North Carolina, 28144, United States
Afferent Investigative Site
Winston-Salem, North Carolina, 27103, United States
Afferent Investigative Site
Cincinnati, Ohio, 45212, United States
Afferent Investigative Site
Cleveland, Ohio, 44109, United States
Afferent Investigative Site
Tiffin, Ohio, 43351, United States
Afferent Investigative Site
Zanesville, Ohio, 43701, United States
Afferent Investigative Site
Bala-Cynwyd, Pennsylvania, 19004, United States
Afferent Investigative Site
Lancaster, Pennsylvania, 17604, United States
Afferent Investigative Site
Myrtle Beach, South Carolina, 29572, United States
Afferent Investigative Site
Dallas, Texas, 75390, United States
Afferent Investigative Site
Fort Worth, Texas, 76104, United States
Afferent Investigative Site
Houston, Texas, 77062, United States
Afferent Investigative Site
Irving, Texas, 75062, United States
Afferent Investigative Site
Salt Lake City, Utah, 84124, United States
Afferent Investigative Site
Virginia Beach, Virginia, 23462, United States
Related Publications (1)
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.
PMID: 32734597DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
April 13, 2012
Primary Completion
May 1, 2014
Study Completion
May 14, 2014
Last Updated
August 17, 2020
Results First Posted
January 12, 2017
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf