The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Subjects With Interstitial Cystitis /Bladder Pain Syndrome
|ClinicalTrials.gov Identifier: NCT01569438|
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : January 12, 2017
Last Update Posted : May 17, 2017
|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 :||March 31, 2012|
|Actual Primary Completion Date :||May 31, 2014|
|Actual Study Completion Date :||May 31, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569438
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