Status:
COMPLETED
Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
Shaare Zedek Medical Center
Conditions:
Headache
Fasting
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01148303
Start Date
July 1 2010
End Date
August 1 2010
Last Update
March 8 2011
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel