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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-08-31

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.

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Detailed Description

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Conditions

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Headache Fasting Fasting Headache Ramadan Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Etoricoxib First

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

Group Type EXPERIMENTAL

Etoricoxib

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo

Etoricoxib Second

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

Group Type EXPERIMENTAL

Etoricoxib

Intervention Type DRUG

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.

Placebo

Intervention Type DRUG

Placebo

Interventions

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Etoricoxib

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.

Intervention Type DRUG

Etoricoxib

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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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arcoxia Arcoxia

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes