A Multi-Center, Randomized, Double-Blind, Placebo- (Double-Dummy) and Active-Controlled, Parallel-Group Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 15
- 主要终点
- Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
研究概览
简要总结
MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.
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
- •Requirement for a primary unilateral bunionectomy
- •Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- •Pain Intensity (PI) using a Numeric Rating Scale (NRS-R) ≥4 at any given timepoint during the 9 hours after removal of the popliteal sciatic block
- •Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 9 hours after removal of the popliteal sciatic block
- •Able to understand and complete the study requirements (including literacy, to enable diary and questionnaire completion), provide written informed consent, and agree to abide by the study protocol and its restrictions.
排除标准
- •Previously dosed with this formulation of MR-107A-
- •Subjects with a contralateral foot bunionectomy in the past 6 months.
- •Subject has a concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain that is not strictly related to the bunionectomy, and which may confound the postoperative assessments.
- •Known hypersensitivity to aspirin, NSAIDs or other medication used in the study.
- •Body mass index (BMI) >40 kg/m2 at screening.
- •Body weight of <43 kg at screening.
- •History of GI bleeding or peptic ulcer disease.
- •Known active inflammatory bowel disease, e.g., Crohn's Disease or ulcerative colitis.
- •A history of bleeding disorders that may affect coagulation.
- •Subjects with prior stroke or transient ischemic attack in the past 12 months prior to screening.
研究组 & 干预措施
MR-107A-02
15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .
干预措施: MR-107A-02 (Drug)
MR-107A-02
15 mg Twice daily (BID) during in patient phase (0-48 hours following randomization) 15 mg BID dosing morning and evening, during out patient phase (5 days) .
干预措施: Bunionectomy (Procedure)
Tramadol
50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).
Placebo will be administered during out patient phase.
干预措施: Tramadol (Drug)
Tramadol
50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).
Placebo will be administered during out patient phase.
干预措施: Placebo (Drug)
Tramadol
50 mg, administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization).
Placebo will be administered during out patient phase.
干预措施: Bunionectomy (Procedure)
Placebo
Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.
干预措施: Placebo (Drug)
Placebo
Placebo is administered every 6 hours (q6h) during the in patient phase (0-48 hours following randomization) and twice daily during the out patient phase.
干预措施: Bunionectomy (Procedure)
结局指标
主要结局
Summed Pain Intensity Difference (SPID) for MR-107A-02 versus placebo.
时间窗: 48 hours after randomization
SPID based on a 0 to 10-point numeric rating scale at rest (NRS-R) for MR-107A-02 versus placebo.
次要结局
- Number of doses of opioid rescue medication taken for MR-107A-02 versus placebo.(7 days after randomization)
- Proportion of subjects using no opioid rescue medication MR-107A-02 versus placebo.(7 days after randomization)