Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Headache
研究概览
简要总结
The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia) taken just before the Ramadan fast will prevent or lessen headache that some people get while fasting. The investigators hypothesize that etoricoxib will reduce the number of people getting headache, more than placebo. The investigators will do this by giving participants in the study either real medication or placebo (sugar pill) and comparing the results. The investigators will study this over two weeks. The first week one group will get the medicine and the other the placebo. The second the groups will switch. Neither the subjects nor the investigators will know who is in which group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
- •Patient states that he/she typically suffered from headache during fasting in the past.
排除标准
- •Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract
- •Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
- •Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control
- •Severe hepatic dysfunction
- •Estimated renal creatinine clearance <30 ml/min
- •History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease
- •Congestive heart failure
- •Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
- •Cancer or any other malignant disease
- •History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)
研究组 & 干预措施
Etoricoxib First
This arm will receive etoricoxib for six days, followed by placebo for eight days.
干预措施: Etoricoxib (Drug)
Etoricoxib First
This arm will receive etoricoxib for six days, followed by placebo for eight days.
干预措施: Placebo (Drug)
Etoricoxib Second
This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
干预措施: Etoricoxib (Drug)
Etoricoxib Second
This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
干预措施: Placebo (Drug)
结局指标
主要结局
Headache
时间窗: Two weeks
The subjects will be asked to fill out a daily 'headache diary' at the end of the fast. They will be asked if they had a headache on that day, and if so its severity. We will then compare the number of subjects having a headache on each day and total number of 'headache days' between the groups.
次要结局
- Severity of Headache(Two weeks)
- Overall ease of fast(Two weeks)
- Side effects and other symptoms(two weeks)