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 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bladder Pain Syndrome||Drug: Gefapixant Drug: Sugar Pill||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Actual Study Start Date :||April 13, 2012|
|Actual Primary Completion Date :||May 1, 2014|
|Actual Study Completion Date :||May 14, 2014|
|Placebo Comparator: Sugar Pill||
Drug: Sugar Pill
- 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.
- 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.
- 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.
- 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.
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
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