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

Hartford Hospital

Status and phase: Completed; Phase 4

Conditions: Ramadan Headache; Fasting; Fasting Headache; Headache

Treatments: Drug: Placebo; Drug: Etoricoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT01148303

ARX_ISP_IL1001

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Etoricoxib First

Experimental group

Description:

This arm will receive etoricoxib for six days, followed by placebo for eight days.

Treatment:

Drug: Placebo

Drug: Etoricoxib

Drug: Etoricoxib

Etoricoxib Second

Experimental group

Description:

This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.

Treatment:

Drug: Placebo

Drug: Etoricoxib

Drug: Etoricoxib