Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 主要终点
- Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
研究概览
简要总结
This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.
详细描述
Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-40 years of age
- •Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
- •Moderate or severe pain within 6 hours of completion of surgery
排除标准
- •Other oral surgical procedures during the same session except the removal of supernumerary third molars
- •Evidence 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
- •Allergy to shellfish
- •Additional Inclusion/Exclusion Criteria May Apply
研究组 & 干预措施
4
Intravenous morphine
干预措施: Intravenous morphine (Drug)
1
Intranasal morphine 7.5 mg
干预措施: Intranasal morphine 7.5 mg (Drug)
2
Intranasal morphine 15 mg
干预措施: Intranasal Morphine 15 mg (Drug)
3
Oral morphine 60 mg
干预措施: Immediate Release Oral Morphine 60 mg (Drug)
5
Intranasal placebo
干预措施: Intranasal Placebo (Drug)
6
Oral placebo
干预措施: Oral placebo (Drug)
7
Intravenous placebo
干预措施: Intravenous placebo (Drug)
结局指标
主要结局
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
时间窗: 2 hours
次要结局
- Other measures of pain relief(Several time points)