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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01569438
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : January 12, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE March 30, 2012
First Posted Date  ICMJE April 3, 2012
Results First Submitted Date  ICMJE September 23, 2016
Results First Posted Date  ICMJE January 12, 2017
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE April 13, 2012
Actual Primary Completion Date May 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
The Primary Efficacy Endpoint of This Study is Change in the 'Average Pain' NPRS Score. [ Time Frame: Baseline and 4 Weeks ]
Subjects were instructed to select a number on a scale that best described the severity of bladder pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst pain possible. The scale was completed by telephone (an interactive voice response system[IVRS]) every evening at bedtime.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
The Primary Efficacy Endpoint of This Study is Change From Baseline in the 'Average Pain' NPRS Score. [ Time Frame: 4 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2017)
  • Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) [ Time Frame: Baseline and 4 Weeks ]
    The PBIC-SD was an 8-item subject self-report measure for assessing the severity of bladder pain syndrome. All items were graded on a scale from 0 (good condition) to 4 (poor condition) for a total score between 0 and 32.
  • O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline and 4 Weeks ]
    The ICSI contains 4 items that measured how problematic symptoms were for subjects with bladder pain syndrome. Each question in the ICPI was on a scale of 0-4, where each answer was given a specific rating. The sum of the item scores indicated more problematic symptoms. The index score ranged from 0-16 where higher scores indicated more problematic symptoms.
  • Genitourinary Pain Index (GUPI) [ Time Frame: Baseline and 4 Weeks ]
    The GUPI is an instrument that is used to assess the degree of symptoms in women with genitourinary pain complaints. The sum of the items yields three subscales and a total score. The subscales are pain (0-23), urinary (0-10), and quality of life (0-12). The sum of the subscales is the total score (0-45). Higher scores indicate more severe symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
  • Numeric Pain Rating Scale Scores [ Time Frame: 4 Weeks ]
  • Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) [ Time Frame: 4 Weeks ]
  • O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: 4 Weeks ]
  • O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 4 Weeks ]
  • Genitourinary Pain Index (GUPI) [ Time Frame: 4 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Subjects With Interstitial Cystitis /Bladder Pain Syndrome
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female subjects 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 subjects with moderate to severe IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bladder Pain Syndrome
Intervention  ICMJE
  • Drug: Gefapixant
    BID
    Other Names:
    • AF-219
    • MK-7264
  • Drug: Sugar Pill
    Placebo
Study Arms  ICMJE
  • Experimental: Gefapixant
    Intervention: Drug: Gefapixant
  • Placebo Comparator: Sugar Pill
    Intervention: Drug: Sugar Pill
Publications * 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:CD013325. doi: 10.1002/14651858.CD013325.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2016)
74
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2012)
150
Actual Study Completion Date  ICMJE May 14, 2014
Actual Primary Completion Date May 1, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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 during the study and 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01569438
Other Study ID Numbers  ICMJE 7264-005
AF219-005 ( Other Identifier: Afferent Pharmaceuticals )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Afferent Pharmaceuticals, Inc.
Study Sponsor  ICMJE Afferent Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Afferent Pharmaceuticals, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP