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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

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bladder Pain Syndrome
Interventions Drug: Gefapixant
Drug: Sugar Pill
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugar Pill Gefapixant
Hide Arm/Group Description Sugar Pill: Placebo Gefapixant: BID
Period Title: Overall Study
Started 38 36
Completed 36 27
Not Completed 2 9
Reason Not Completed
Adverse Event             0             7
Lack of Efficacy             1             1
Withdrawal by Subject             0             1
Protocol Violation             1             0
Arm/Group Title Gefapixant Sugar Pill Total
Hide Arm/Group Description Gefapixant: BID Sugar Pill: Placebo Total of all reporting groups
Overall Number of Baseline Participants 36 38 74
Hide Baseline Analysis Population Description
Titration Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  77.8%
38
 100.0%
66
  89.2%
>=65 years
8
  22.2%
0
   0.0%
8
  10.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
Female
36
 100.0%
38
 100.0%
74
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
Hispanic or Latino
3
   8.3%
0
   0.0%
3
   4.1%
Not Hispanic or Latino
33
  91.7%
38
 100.0%
71
  95.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 38 participants 74 participants
American Indian or Alaska Native
2
   5.6%
0
   0.0%
2
   2.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   8.3%
3
   7.9%
6
   8.1%
White
29
  80.6%
35
  92.1%
64
  86.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.6%
0
   0.0%
2
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 38 participants 74 participants
36 38 74
Numeric Pain Rating Scale (NPRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 36 participants 38 participants 74 participants
6.2  (1.44) 6.4  (1.12) 6.3  (1.28)
[1]
Measure Description: Subjects were instructed to select a number between 0 and 10 where 0 is no pain and 10 is the worst pain possible. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime. In order to qualify for study entry, subjects must have had an average score of >=4 and <10 during the baseline assessment phase.
1.Primary Outcome
Title The Primary Efficacy Endpoint of This Study is Change in the 'Average Pain' NPRS Score.
Hide Description 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.
Time Frame Baseline and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase
Arm/Group Title Gefapixant Sugar Pill
Hide Arm/Group Description:
Gefapixant: BID
Sugar Pill: Placebo
Overall Number of Participants Analyzed 26 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (1.85) 4.5  (2.14)
2.Secondary Outcome
Title Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD)
Hide Description 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.
Time Frame Baseline and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase
Arm/Group Title Gefapixant Sugar Pill
Hide Arm/Group Description:
Gefapixant: BID
Sugar Pill: Placebo
Overall Number of Participants Analyzed 26 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.3  (7.08) 15.3  (7.59)
3.Secondary Outcome
Title O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
Hide Description 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.
Time Frame Baseline and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase
Arm/Group Title Gefapixant Sugar Pill
Hide Arm/Group Description:
Gefapixant: BID
Sugar Pill: Placebo
Overall Number of Participants Analyzed 26 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.7  (4.65) 10.3  (3.77)
4.Secondary Outcome
Title Genitourinary Pain Index (GUPI)
Hide Description 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.
Time Frame Baseline and 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase
Arm/Group Title Gefapixant Sugar Pill
Hide Arm/Group Description:
Gefapixant: BID
Sugar Pill: Placebo
Overall Number of Participants Analyzed 26 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.8  (10.87) 25.5  (9.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill Gefapixant
Hide Arm/Group Description Sugar Pill: Placebo Gefapixant: BID
All-Cause Mortality
Sugar Pill Gefapixant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Sugar Pill Gefapixant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/36 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sugar Pill Gefapixant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/38 (26.32%)      31/36 (86.11%)    
Nervous system disorders     
Dysgeusia  5/38 (13.16%)  5 26/36 (72.22%)  26
Headache  5/38 (13.16%)  5 5/36 (13.89%)  5
Ageusia  0/38 (0.00%)  0 3/36 (8.33%)  3
Hypogeusia  0/38 (0.00%)  0 3/36 (8.33%)  3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
60 days prior to the submission of any results, the PI shall submit to SPONSOR any proposed PUBLICATION, which period may be extended for an additional 30 days if requested by SPONSOR. If any Confidential Information should be redacted or patent applications relating to an Invention should be filed prior to PUBLICATION, then PUBLICATION will be delayed until patent application has been filed. Delay of a PUBLICATION shall not exceed 24 months from the date of such notice to the PI.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Development
Organization: Afferent Pharmaceuticals
Phone: 650-286-1276
EMail: info@afferentpharma.com
Layout table for additonal information
Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01569438    
Other Study ID Numbers: 7264-005
AF219-005 ( Other Identifier: Afferent Pharmaceuticals )
First Submitted: March 30, 2012
First Posted: April 3, 2012
Results First Submitted: September 23, 2016
Results First Posted: January 12, 2017
Last Update Posted: June 9, 2020