Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 主要终点
- VAS Total Pain Relief 0-4 hours (TOTPAR4)
研究概览
简要总结
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.
详细描述
Diagnosis and Main Criteria for Inclusion:
Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.
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
- •Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study.
- •18 years of age or older
- •Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery
排除标准
- •Allergy to shellfish
- •Signs of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety.
- •Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
- •Additional Inclusion/Exclusion Criteria May Apply
研究组 & 干预措施
1
Intranasal morphine 3.75 mg
干预措施: Intranasal Morphine (MNS075) 3.75 mg (Drug)
2
Intranasal morphine 7.5 mg
干预措施: Intranasal morphine (MNS075) 7.5 mg (Drug)
3
Intranasal morphine 15 mg
干预措施: Intranasal morphine (MNS075) 15 mg (Drug)
4
Intranasal morphine 30 mg
干预措施: Intranasal morphine (MNS075) 30 mg (Drug)
5
Intravenous morphine 7.5 mg
干预措施: Intravenous Morphine 7.5 mg (Drug)
6
Intranasal placebo
干预措施: Intranasal placebo (Drug)
结局指标
主要结局
VAS Total Pain Relief 0-4 hours (TOTPAR4)
时间窗: 4 hours
次要结局
- Other measures of pain relief(Several time points)