A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Overall Summed Pain Intensity Difference (SPID)
研究概览
简要总结
MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after dental surgery.
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
- •Males and females ≥18 years of age.
- •Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of which involves partial or complete mandibular bony impaction.
- •Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours following the end of surgery.
- •Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery.
排除标准
- •Previously dosed with MR-107A-
- •Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).
- •Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may affect coagulation.
- •Use of any investigational drug within 28 days, or 5 half-lives, prior to screening whichever is longer.
- •Use of medications with the potential to interact with MR-107A-
- •Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
研究组 & 干预措施
MR-107A-01 15 mg twice in a 24-hour period
Oral tablet one day of dosing
干预措施: MR-107A-01 (Drug)
MR-107A-01 10 mg twice in a 24-hour period
Oral tablet one day of dosing
干预措施: MR-107A-01 (Drug)
MR-107A-01 15 mg once in a 24-hour period
Oral tablet one day of dosing
干预措施: MR-107A-01 (Drug)
MR-107A-01 10 mg once in a 24-hour period
Oral tablet one day of dosing
干预措施: MR-107A-01 (Drug)
Placebo twice in a 24-hour period
Placebo tablet one day of dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Summed Pain Intensity Difference (SPID)
时间窗: 24 hours after the first dose
Participants assessed Pain Intensity (PI) using a 0-10 numeric pain rating scale (NPRS) where 0 is no pain and 10 is worst pain imaginable. PI was assessed 17 times within 24 hours after the first study dose, and immediately before any rescue medication and/or at early termination. The participant's baseline PI was subtracted from the timepoint PI, to derive a Pain Intensity Difference (PID) for each timepoint. Overall Summed Pain Intensity Difference (SPID) measures pain intensity change relative to baseline over the 24 hour period after dosing, and corresponds to the Area Under the Curve (AUC) of the PID. In this study, higher positive Overall SPID indicates better pain improvement. Overall SPID could range from -120 to 240. Two hour windowed last observation carried forward was used as applicable where PI score obtained before a rescue medication replaced PI score for each timepoint within 2 hours following rescue dose.
次要结局
- Rescue Medication Use(24 hours after the first dose)
- Total Pain Relief(24 hours after the first dose)
- Patient's Global Assessment of Pain Control(24 hours after the first dose)
- Pain Intensity Using a Numeric Pain Rating Scale Utilizing 2-hour Windowed Last Observation Carried Forward (W2LOCF)(24 hours after the first dose)
- Pain Relief: Number and Percentage of Subjects With Perceptible and Meaningful Pain Relief(24 hours after the first dose)