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)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Gefapixant (Drug)
Placebo
Female participants receive dose matched placebo tablets, BID, orally, with food for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4
时间窗: 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.
次要结局
- Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4(Baseline and Week 4)
- Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4(Baseline and Week 4)
- Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4(Baseline and Week 4)