A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,068
- 试验地点
- 2
- 主要终点
- 2-hour pain-free
研究概览
简要总结
A phase III study, multicenter, double-blind, double-dummy, randomized, single-dose, placebo-controlled study to evaluate the efficacy and safety of Rizatriptan-Naproxen (10/550 mg) in the acute treatment of migraine.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
详细描述
This is a prospective, randomized, double-blind, double-dummy and placebo-controlled study in individuals with disabling migraine. The participants will be randomized to receive Rizatriptan + Naproxen (10/550mg), Rizatriptan (10mg), Naproxen (550mg) or placebo.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients of both sexes;
- •Aged between 18 and 65 years old;
- •Capable and willing to give free and informed informed consent in writing;
- •Migraine patients with or without aura, according to the International Headache Society (IHS).
排除标准
- •Chronic migraine;
- •Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo oral tablet (Drug)
Rizatriptan 10mg+ Naproxen 550mg
Rizatriptan 10mg+ Naproxen 550mg
干预措施: Rizatriptan 10 mg + Naproxen 550mg (Drug)
Flanax 550mg
Naproxen 550mg
干预措施: Flanax 550mg (Drug)
Maxalt 10mg
Rizatriptan10mg
干预措施: Maxalt 10Mg Tablet (Drug)
结局指标
主要结局
2-hour pain-free
时间窗: 11 weeks
2-hour pain-free response (Proportion of participants reporting pain freedom at two hours post-dose)
次要结局
- Most bothersome migraine-associated symptom(11 weeks)