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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 Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)

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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.

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 August 17, 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: August 6, 2020)
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.
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: August 6, 2020)
  • 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.
  • 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.
  • 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.
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 Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Bladder Pain Syndrome
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Dose matched placebo tablets, BID, orally, with food for 4 weeks
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Gefapixant
  • Placebo Comparator: Placebo
    Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
    Intervention: Drug: Placebo
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.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 6, 2020)
107
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 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
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 )
MK-7264-005 ( Other Identifier: Merck Protocol Number )
Has Data Monitoring Committee Yes
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
Study Director: Medical Director Afferent Pharmaceuticals, Inc.
PRS Account Afferent Pharmaceuticals, Inc.
Verification Date August 2020

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