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

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 : Terminated
First Posted : April 3, 2012
Results First Posted : January 12, 2017
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
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)
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
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.
Drug: Gefapixant
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
Other Names:
  • AF-219
  • MK-7264

Placebo Comparator: Placebo
Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
Drug: Placebo
Dose matched placebo tablets, BID, orally, with food for 4 weeks




Primary Outcome Measures :
  1. Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4 [ Time Frame: Baseline and 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.


Secondary Outcome Measures :
  1. Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4 [ Time Frame: Baseline and Week 4 ]
    To assess the severity of bladder pain syndrome (BPS), an 8-item participant self-report PBIC-SD measure was used. Participants were asked to select a number on the scale that best described the severity of bladder pain over telephone using an IVRS each evening on the three consecutive days (during the Baseline Assessment Phase and during each Treatment Week up to 4 weeks). Each item was graded on a scale from 0 (good condition) to 4 (poor condition) with a total score range 0-32. Higher scores indicate more severe BPS. The analysis was conducted using a MMRM approach to calculate the LS mean change from baseline PBIC-SD total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.

  2. Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4 [ Time Frame: Baseline and Week 4 ]
    To measure the severity of BPS (urgency and frequency of urination, nighttime urination, and pain or burning) over past month, a 4-item self-report ICSI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The ICSI score range from 0 (Not at all) to 5 (Almost always) for the first 3 items and a score of 0 (Not at all) to 4 (Almost always) for the last item, with an index score range of 0-19. Higher scores indicate more severe BPS. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline ICSI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.

  3. Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4 [ Time Frame: Baseline and Week 4 ]
    To measure the degree of genitourinary pain symptoms, an 8-item self-report GUPI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The GUPI instrument yields a total score of 0-45 and 3 subscales: pain (score = 0-23), urinary (score = 0-10), and quality of life (score = 0-12). Higher scores indicate more severe symptoms. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline GUPI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in degree of genitourinary pain symptoms.



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01569438


Locations
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United States, Alabama
Afferent Investigative Site
Glendale, Alabama, United States, 85306
Afferent Investigative Site
Homewood, Alabama, United States, 35209
Afferent Investigative Site
Mobile, Alabama, United States, 36608
United States, Arizona
Afferent Investigative Site
Phoenix, Arizona, United States, 85018
United States, California
Afferent Investigative Site
Glendora, California, United States, 91741
Afferent Investigative Site
Murrieta, California, United States, 91741
Afferent Investigative Site
San Diego, California, United States, 92120
Afferent Investigative Site
San Diego, California, United States, 92123
United States, Connecticut
Afferent Investigative Site
Farmington, Connecticut, United States, 06032
Afferent Investigative Site
New Britain, Connecticut, United States, 06052
United States, Florida
Afferent Investigative Site
Boynton Beach, Florida, United States, 33472
Afferent Investigative Site
Plantation, Florida, United States, 33317
United States, Idaho
Afferent Investigative Site
Coeur d'Alene, Idaho, United States, 83814
Afferent Investigative Site
Idaho Falls, Idaho, United States, 83404
Afferent Investigative Site
Meridian, Idaho, United States, 83642
United States, Louisiana
Afferent Investigative Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
Afferent Investigative Site
Annapolis, Maryland, United States, 21401
United States, Michigan
Afferent Investigative Site
Ann Arbor, Michigan, United States, 48109
Afferent Investigative Site
Grand Rapids, Michigan, United States, 49503
Afferent Investigative Site
Kalamazoo, Michigan, United States, 49009
Afferent Investigative Site
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Afferent Investigative Site
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Afferent Investigative Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Afferent Investigative Site
Brooklyn, New York, United States, 11215
Afferent Investigative Site
Hyde Park, New York, United States, 11040
United States, North Carolina
Afferent Investigative Site
Greenville, North Carolina, United States, 27834
Afferent Investigative Site
Salisbury, North Carolina, United States, 28144
Afferent Investigative Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Afferent Investigative Site
Cincinnati, Ohio, United States, 45212
Afferent Investigative Site
Cleveland, Ohio, United States, 44109
Afferent Investigative Site
Tiffin, Ohio, United States, 43351
Afferent Investigative Site
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Afferent Investigative Site
Bala-Cynwyd, Pennsylvania, United States, 19004
Afferent Investigative Site
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Afferent Investigative Site
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Afferent Investigative Site
Dallas, Texas, United States, 75390
Afferent Investigative Site
Fort Worth, Texas, United States, 76104
Afferent Investigative Site
Houston, Texas, United States, 77062
Afferent Investigative Site
Irving, Texas, United States, 75062
United States, Utah
Afferent Investigative Site
Salt Lake City, Utah, United States, 84124
United States, Virginia
Afferent Investigative Site
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Afferent Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01569438    
Other Study ID Numbers: 7264-005
AF219-005 ( Other Identifier: Afferent Pharmaceuticals )
MK-7264-005 ( Other Identifier: Merck Protocol Number )
First Posted: April 3, 2012    Key Record Dates
Results First Posted: January 12, 2017
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases