Clinical trial NCT01569438: The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bladder Pain Syndrome
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Afferent Investigative Site
state: Alabama
city: Homewood
country: United States
facility: Afferent Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Afferent Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Afferent Investigative Site
state: Arizona
city: Glendora
country: United States
facility: Afferent Investigative Site
state: California
city: Murrieta
country: United States
facility: Afferent Investigative Site
state: California
city: San Diego
country: United States
facility: Afferent Investigative Site
state: California
city: San Diego
country: United States
facility: Afferent Investigative Site
state: California
city: Farmington
country: United States
facility: Afferent Investigative Site
state: Connecticut
city: New Britain
country: United States
facility: Afferent Investigative Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Afferent Investigative Site
state: Florida
city: Plantation
country: United States
facility: Afferent Investigative Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Afferent Investigative Site
state: Idaho
city: Idaho Falls
country: United States
facility: Afferent Investigative Site
state: Idaho
city: Meridian
country: United States
facility: Afferent Investigative Site
state: Idaho
city: Shreveport
country: United States
facility: Afferent Investigative Site
state: Louisiana
city: Annapolis
country: United States
facility: Afferent Investigative Site
state: Maryland
city: Ann Arbor
country: United States
facility: Afferent Investigative Site
state: Michigan
city: Grand Rapids
country: United States
facility: Afferent Investigative Site
state: Michigan
city: Kalamazoo
country: United States
facility: Afferent Investigative Site
state: Michigan
city: Royal Oak
country: United States
facility: Afferent Investigative Site
state: Michigan
city: Voorhees
country: United States
facility: Afferent Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Afferent Investigative Site
state: New Mexico
city: Brooklyn
country: United States
facility: Afferent Investigative Site
state: New York
city: Hyde Park
country: United States
facility: Afferent Investigative Site
state: New York
city: Greenville
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Afferent Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Tiffin
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Zanesville
country: United States
facility: Afferent Investigative Site
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Afferent Investigative Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Afferent Investigative Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Afferent Investigative Site
state: South Carolina
city: Dallas
country: United States
facility: Afferent Investigative Site
state: Texas
city: Fort Worth
country: United States
facility: Afferent Investigative Site
state: Texas
city: Houston
country: United States
facility: Afferent Investigative Site
state: Texas
city: Irving
country: United States
facility: Afferent Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Afferent Investigative Site
state: Utah
city: Virginia Beach
country: United States
facility: Afferent Investigative Site
state: Virginia
Study officials:
affiliation: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.