Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Conditions
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Headache, Fasting, Fasting Headache, Ramadan Headache

Intervention / Treatment
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* Drug: Etoricoxib
* Drug: Etoricoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 -65. 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etoricoxib First<br>This arm will receive etoricoxib for six days, followed by placebo for eight days. | Drug: Etoricoxib<br>* Subjects will take etoricoxib 90mg by mouth just before the start of the daily fast. This will be for six days. After this they will receive placebo for eight days.<br>* Other names: arcoxia;Drug: Placebo<br>* Placebo<br>|
| Experimental: Etoricoxib Second<br>This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days. | Drug: Etoricoxib<br>* This arm will receive placebo just before their fast for eight days. After this they will receive etoricoxib 90mg just before their daily fast for the next six days.<br>* Other names: Arcoxia;Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache | 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. | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Headache | We will ask the subject if they had a headache on a given day to rate its severity. We will then compare the severity of headache between groups. | Two weeks | 
| Overall ease of fast | We will ask subjects to rate the ease of their fast on a daily basis on a 5 point scale and will compare general ease of fast between the groups. | Two weeks | 
| Side effects and other symptoms | We will ask subjects to record other symptoms or side effects they had during the fast including nausea, abdominal pain, photophobia, difficulty breathing or other. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Fasting, Fasting Headache, Ramadan, Ramadan Headache, Yom Kippur, Yom Kippur Headache