Randomized, Double-Blind, Active- and Placebo-Controlled Study of Analgesic Efficacy and Safety of Repeated Dosing of MNS075 (Intranasal Morphine), IV Morphine, and Placebo in Acute Post-Operative Pain After Elective Orthopedic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 6
- 主要终点
- Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
研究概览
简要总结
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
详细描述
Multiple-center, multiple-dose, randomized, double-blind, six-arm, active- and placebo-controlled study of repeated intermittent PRN dosing for 24 hours of Intranasal (IN) Morphine Nasal Spray (MNS075) 7.5 mg and 15 mg, 7.5 mg IV morphine infusions and placebo (either IN or IV), in patients with moderate to severe post-surgical pain from elective orthopedic surgery with safety observed for a total of 30 hours post first dose.
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
- •Over 18 years old
- •Scheduled (within two weeks of the screening visit) to undergo elective orthopedic surgery (e.g., bunionectomy, arthroscopic knee surgery, rotator cuff repair)
- •Moderate to severe pain within 8 hours following completion of the required surgery
排除标准
- •Previous anaphylactic or serious allergic reaction to shellfish or opioids
- •History of sleep apnea
- •Other Inclusion/Exclusion Criteria May Apply
研究组 & 干预措施
A
MNS075 7.5mg
干预措施: Intranasal morphine (Drug)
B
Placebo
干预措施: Placebo (Drug)
C
IV Morphine
干预措施: IV morphine (Drug)
E
MNS075 15mg
干预措施: Intranasal morphine (Drug)
D
Placebo
干预措施: Placebo (Drug)
F
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Sum of the Pain Intensity Differences (SPID) over 0-24 hours based on Visual Analog Scale (VAS)
时间窗: Multiple
次要结局
- Other measures of pain(Multiple)