NCT00483717已完成2 期
A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
研究概览
简要总结
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
详细描述
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
- •Onset of migraine prior to age 50;
- •2-8 moderate to severe migraine headaches per month
排除标准
- •Subjects receiving any investigational drug within 30 days before study entry;
- •More than 15 headache days per month;
- •Known allergy or hypersensitivity to ketorolac and/or excipients;
- •Allergy to aspirin or other NSAIDs;
- •Currently receiving other NSAIDs or aspirin;
- •Medical history that would preclude NSAID use
研究组 & 干预措施
Placebo
Placebo Comparator
Intranasal Placebo
干预措施: Placebo (Drug)
Ketorolac tromethamine
Experimental
Intranasal ketorolac tromethamine
干预措施: Ketorolac tromethamine (Drug)
结局指标
主要结局
The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
时间窗: 2 hours after dosing
Pain was evaluated using a 4-point International Headache Society (IHS) scale where grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain
次要结局
- The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point(48 hours post-dosing)
研究者
研究点 (1)
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