NCT05248997已完成3 期
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Chronic Rhinosinusitis (CRS) With or Without Nasal Polyps
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 261
- 试验地点
- 33
- 主要终点
- Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit.
- •Subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat CRS symptoms during the course of the study.
- •Subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding.
- •No clinically significant abnormality identified on the medical or laboratory evaluation.
排除标准
- •Subject has primary headache disorder.
- •Subject has history of nasal or facial surgery within the 6 months prior to screening.
- •Subject has ongoing rhinitis medicamentosa.
- •Subject has diagnosed or suspected invasive fungal rhinosinusitis.
- •Subject is currently receiving aspirin desensitization or maintenance therapy for Samter's Triad.
- •Subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (ABRS) without signs or symptoms of rhinosinusitis between episodes).
- •Body Mass Index > 35.0kg/m2
- •Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
- •Subjects taking/using excluded therapies.
- •Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
- •Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
- •Planned participation in any other investigational clinical trial while participating in this clinical trial.
研究组 & 干预措施
rimegepant 75 mg ODT
Active Comparator
One dose of rimegepant 75 mg ODT
干预措施: rimegepant 75 mg ODT (Drug)
Matching Placebo
Active Comparator
One dose of matching placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose
时间窗: Baseline, 2 hours post-dose
Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
次要结局
- Change From Baseline in Total Nasal Symptom Score (TNSS) at 2 Hours Post-Dose(Baseline, 2 hours post-dose)
- Change From Baseline in Nasal Obstruction (Congestion) at 2 Hours Post-Dose(Baseline, 2 hours post-dose)
- Change From Baseline in Nasal Discharge at 2 Hours Post-Dose(Baseline, 2 hours post-dose)
- Percentage of Participants With Headache Pain Relief at 2 Hours Post-Dose(2 hours post-dose)
- Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-dose(Through 24 hours post-dose)
研究者
研究点 (33)
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