NCT02183688已完成3 期
A Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
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
- 1,889
- 主要终点
- Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS)
研究概览
简要总结
To confirm the combination rationale for the combination of ASA + paracetamol + caffeine compared with the combination of ASA + paracetamol and the individual substances ASA, paracetamol, caffeine, and placebo administered orally to headache patients for two headache episodes
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
- •Female or male out-patients aged between 18 and 65 years
- •Diagnosis: Headache
- •Tension type headache according to international headache society (IHS) Headache Classification 2.1 (2.1.1 and 2.1.2) and/or
- •Migraine according to IHS Headache Classification 1.1, 1.2.1 or
- •Either a) or b), but cannot be distinctly classified
- •The patient normally treats his/her headache successfully with non-prescription analgesics
- •He/She has been suffering from headache for 12 months at least
- •The headache first occurred before the age of 50 years
- •During the previous three months, the patient has suffered from headache twice a month at least
- •Informed consent according to §§ 40, 41 of the german medicines act and Good Clinical Practice (GCP)
- •The patient seems likely to comply
排除标准
- •The patient treats his/her headache with prescription-only analgesics or migraine remedies
- •The patient requires higher single doses of non-prescription analgesics to treat his/her headache than indicated in the patient information leaflet (e.g. more than 2 tablets of Thomapyrin tablets)
- •The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
- •The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
- •Headache occurs on more than 10 days per month
- •The typical, untreated headache normally lasts less than 4 hours without treatment
- •Women with a close association between the occurrence of headache and menstruation (menstrual migraine)
- •Concomitant treatment with prescription-only and/or non-prescription analgesics
- •Previous or concomitant treatment with antidepressants or antipsychotic medicines (previous treatment = within the previous 4 weeks)
- •Previous or concomitant treatment with anti-rheumatic or anti-inflammatory drugs that may influence the headache symptoms (previous treatment = within the previous 4 days)
- •Treatment of concomitant illnesses with drugs containing ASA (above a daily dose of 100 mg per day), paracetamol or caffeine (e.g. for feverish common cold, etc.)
- •Migraine prophylaxis or administration of drugs, indicated for any other reasons that influence headache symptoms, e.g.
- •Propanolol, Metoprolol, Flunarizine, Cyclandelate, Valproic acid, Serotonin antagonists (pizotifen, methysergide, lisuride), Ergotamine, Dihydroergotamine, Benzodiazepines, Magnesium, Monoamine oxidase inhibitors
- •Concomitant treatments with anti-emetics
- •Drug abuse connected with the headache (defined as the administration of analgesics or other drugs for the treatment of acute headache on more than 10 days per month)
- •Alcohol or drug abuse as defined by diagnostic and statistical manual of mental disorders (DSM-IV)
- •Pregnancy and lactation
- •Gastrointestinal ulcers
- •Pathologically increased bleeding tendency
- •Glucose-6-phosphate dehydrogenase deficiency
- •Hypersensitivity to paracetamol, caffeine, ASA, salicylates, and other anti-inflammatory/anti-rheumatic agents or other allergenic substances that are relevant to the clinical trial
- •Bronchial asthma
- •Concomitant treatment with anticoagulants (e.g. coumarin derivates, heparin)
- •Clinically relevant chronic or recurrent gastrointestinal symptoms
- •Clinically relevant liver disorders
- •Clinically relevant pre-existing renal damage
- •Gilbert's syndrome
- •Not successfully treated hyperthyroidism
- •Simultaneous participation in another clinical trial
- •Participation in another clinical trial within 4 weeks of entering this study
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ASA + paracetamol + caffeine
Experimental
干预措施: Low dose ASA (Drug)
ASA + paracetamol + caffeine
Experimental
干预措施: Low dose paracetamol (Drug)
ASA + paracetamol + caffeine
Experimental
干预措施: Caffeine (Drug)
ASA + paracetamol
Active Comparator
干预措施: Low dose ASA (Drug)
ASA + paracetamol
Active Comparator
干预措施: Low dose paracetamol (Drug)
ASA
Active Comparator
干预措施: High dose ASA (Drug)
Paracetamol
Active Comparator
干预措施: High dose paracetamol (Drug)
Caffeine
Active Comparator
干预措施: Caffeine (Drug)
结局指标
主要结局
Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS)
时间窗: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
次要结局
- Ratio of weighted sum of pain intensity difference scores to maximum achievable sum of pain intensity differences (%SPIDweighted), evaluated on a VAS(Up to the end of the study)
- Pain intensity, evaluated on a VAS(30 min., 1, 2, 3 and 4 hours after administration of the study medication)
- Duration of headache(Up to 48 hours after onset of each headache episode)
- Extent of impairment of daily activities, evaluated on a 4-grade verbal scale (VRS)(Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug)
- Percentage of patients with 50 % pain relief, evaluated on a VAS(At least 30 min., 1, 3, and 4 hours after administration of the study medication)
- Number of patients with adverse events(Up to the end of the study)
- Global assessment of tolerability by the investigator, evaluated on a 4-grade VRS(After each administration of study drug during the treatment phase)
- Global assessment of efficacy by the patient, evaluated on a 4-grade VRS(Within 12 hours after study drug administration)
- Global assessment of tolerability by the patient, evaluated on a 4-grade VRS(Within 12 hours after study drug administration)
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