NCT02183220已完成3 期
A Randomised, Double Blind, Placebo- and Active-controlled Parallel Group Study Investigating the Efficacy and Tolerability of Metamizol 0.5 g and 1.0 g in Patients With Episodic Moderate Tension Headache.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 417
- 主要终点
- Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
研究概览
简要总结
The objective of the study was to evaluate the efficacy, safety and tolerability of a single peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid in 2 episodes of moderate tension headache.
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
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
- •Male and female patients between 18 and 65 years old
- •Moderate episodic tension headache according to International Headache Society (I.H.S.) classification 2.1 (2.1.1 and 2.1.2) for at least one year
- •At least two episodes of tension headache per month in the last three months prior to enrolment into this trial
- •The episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic
- •First episodic headache occurred at an age under 50 years
- •Written informed consent according to Good Clinical Practice (GCP) and local regulations
- •The patient was able to fill in the Patient's Diary
排除标准
- •The patient usually needs for successful treatment of tension headache "Over The Counter" (OTC) analgesic in doses exceeding the doses tested here
- •The patient takes an OTC-analgesic normally at the first signs of an episode of tension headache
- •The patient has more than 15 episodes of tension headache per month
- •Female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception
- •Concomitant treatment with (non-) prescriptional analgesics
- •Pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment with an antidepressive and/or antipsychotic drug
- •Pre- (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug such as NSAIDs (Non-Steroidal Anti Inflammatory Drugs), propanolol, metroprolol, flunarizin, cyclandelate, valproic-acid, serotonergic antagonists, ergotamine, dihydroergotamines and benzodiazepines that may influence the headache symptomatology
- •Use of benzodiazepines in the previous 24 hours to the administration of the study drug. Occasional use of benzodiazepines - up to 3 per week - is allowed
- •Use of any drug with analgesic properties in the previous 24 hours to the administration of the study drug
- •Concomitant treatment with any drug containing ASA and/or metamizol
- •Concomitant treatment with anticoagulants such as heparin or coumarin-derivatives
- •Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders )
- •Female patients in child-bearing age not using adequate means of birth control
- •Pregnancy and/or lactation
- •Gastrointestinal ulcers
- •Liver and/or renal disease
- •Bronchial asthma
- •Relevant allergy or known hypersensitivity to the investigational drugs, its excipients and/or to other NSAIDs
- •Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- •Patients with active gastroesophageal flux disease (Amendment number 1)
- •Concomitant treatment with analgesics or any other drug that may have influenced the headache symptomatology - including metamizol or ASA -, was referred to its use during the headache episodes under evaluation. As long as appropriate wash-out periods were respected, analgesics were allowed in between the episodes of tension headache (TH) and their use as a rescue medication did not lead to the exclusion of the patient (Amendment number 2)
研究组 & 干预措施
Metamizol high & Placebo
Experimental
干预措施: Metamizol (Drug)
Metamizol high & Placebo
Experimental
干预措施: Metamizol placebo (Drug)
Metamizol low & Placebo
Experimental
干预措施: Metamizol (Drug)
Metamizol low & Placebo
Experimental
干预措施: Metamizol placebo (Drug)
Acetylsalicylic acid & Placebo
Active Comparator
干预措施: Acetylsalicylic acid (ASA) (Drug)
Acetylsalicylic acid & Placebo
Active Comparator
干预措施: ASA placebo (Drug)
Placebo
Placebo Comparator
干预措施: Metamizol placebo (Drug)
Placebo
Placebo Comparator
干预措施: ASA placebo (Drug)
结局指标
主要结局
Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
时间窗: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
次要结局
- Number of patients with at least a 50% pain reduction on a VAS(before and 30 minutes, 1, 2, 3, and 4 hours after drug intake)
- Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)(30 minutes, 1, 2, 3, and 4 hours after drug intake)
- Number of patients using rescue medication(2, 3, and 4 hours after drug intake)
- Total pain relief (TOTPAR) on a VRS(30 minutes, 1, 2, 3, and 4 hours after drug intake)
- Number of patients with adverse events(up to 2 months)
- Global efficacy assessment on a VRS by the patient and investigator(4 hours after drug intake)
- Pain intensity difference (PID) on a VAS(before and 30 minutes, 1, 2, 3, and 4 hours after drug intake)
- Maximum pain intensity difference (MAXPID) on a VAS(before and 30 minutes, 1, 2, 3, and 4 hours after drug intake)
- Time to 50% pain intensity reduction on a VAS(before and 30 minutes, 1, 2, 3, and 4 hours after drug intake)
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