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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. Identifier: NCT01569438
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : January 12, 2017
Last Update Posted : June 26, 2019
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to assess the efficacy of a single dose level 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.

Condition or disease Intervention/treatment Phase
Bladder Pain Syndrome Drug: Gefapixant Drug: Sugar Pill Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : April 13, 2012
Actual Primary Completion Date : May 1, 2014
Actual Study Completion Date : May 14, 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gefapixant Drug: Gefapixant
Other Names:
  • AF-219
  • MK-7264

Placebo Comparator: Sugar Pill Drug: Sugar Pill

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569438

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Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.

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Responsible Party: Afferent Pharmaceuticals, Inc. Identifier: NCT01569438     History of Changes
Other Study ID Numbers: 7264-005
AF219-005 ( Other Identifier: Afferent Pharmaceuticals )
First Posted: April 3, 2012    Key Record Dates
Results First Posted: January 12, 2017
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Additional relevant MeSH terms:
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Cystitis, Interstitial
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases