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Trial record 1 of 1 for:    NCT01569438
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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 26, 2019
Sponsor:
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
BID
Other Names:
  • AF-219
  • MK-7264

Placebo Comparator: Sugar Pill Drug: Sugar Pill
Placebo




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.



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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 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 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.
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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 )
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: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Cystitis, Interstitial
Syndrome
Disease
Pathologic Processes
Cystitis
Urinary Bladder Diseases
Urologic Diseases