NCT01408069撤回3 期
Multicentric, Randomizade, Double Blind, Double Dummy To Non-Inferiority Comparison Of Migrane® Versus Parcel ® For Treatment Of Tensional Cephaleia
EMS0 个研究点开始时间: 2011年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Efficacy of treatment in relieve headache symptoms.
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.
详细描述
- Open-label, non-inferiority, prospective, parallel group, intent to treat trial.
- Experiment duration: 56 days.
- 04 visits (days -7, 0, 28 and 56).
- Efficacy will be evaluated for 10 episodes of tension-type headache.
- Adverse events evaluation.
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, Care Provider, 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
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Tensional-type headache patients according to the International Headache Society criteria.
- •Corporal body indices < 40.
排除标准
- •Pregnancy or risk of pregnancy.
- •Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
- •Use of immunosuppressive drugs.
- •Alterations of laboratory selective tests.
- •Drugs or alcohol abuse
研究组 & 干预措施
MIGRANE
Experimental
1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg
干预措施: MIGRANE (Drug)
PARCEL
Active Comparator
1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
干预措施: PARCEL (Drug)
结局指标
主要结局
Efficacy of treatment in relieve headache symptoms.
时间窗: 1 hour
The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after 30, 60 and 90 minutes of initiation of treatment.
次要结局
- Tolerability of study treatment(56 days)
研究者
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