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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00263094 |
Fasting is a known trigger for headache. People who fast to comply with religious edict have been shown to be prone to headache which becomes more likely to occur with increasing length of fasting, and in people prone to headache. This has been documented as 'Yom Kippur Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would prevent or attenuate headache when taken just prior to the complete (no food or drink) 25 hour fast of Yom Kippur.
Condition | Intervention |
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Headache |
Drug: Rofecoxib |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | : An End to the Yom Kippur (and Ramadan) Headache: A Double Blind Placebo Controlled Trial of Prophylactic Rofecoxib in Preventing Ritual Fasting Headache. |
Estimated Enrollment: | 220 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | November 2004 |
Introduction: Religious fasting is associated with headache. This has been documented as ‘Yom Kippur Headache’ and ‘ First- of - Ramadan Headache.’ The Cox2 inhibitor, rofecoxib, has been reported effective in preventing perimenstrual migraine and in preventing recurrence of migraine. Given its 17 hour half-life, we undertook this study to see whether 50mg rofecoxib taken just prior to the 25 hour Yom Kippur fast would be effective in preventing headache.
Methods: We performed a double blind randomized prospective trial of rofecoxib 50mg vs placebo, taken just prior to the onset of fasting, Yom Kippur 2004. Healthy adults aged 18 – 65 were enrolled from the community and from hospital staff. Subjects completed a demographic data form and questions regarding headache history and a post-fast survey on headache during the fast, headache intensity, general ease of fasting and side effects.
Results: We sent out 170 forms of which 105 were completed and returned. Of those subjects receiving rofecoxib (n=53), ten or 18.9% vs 34 or 65.4 % of the placebo group (n=52) had headache at some point during the fast (p<.0001). Severity of headache in the treatment group was significantly less for the treatment group (3.45 vs 6.29 on a visual analog scale of 10 (p = .009)). None of those receiving rofecoxib reported a ‘more difficult than usual fast’ whereas the distribution of difficult to easy fast among the placebo group was more even.
Conclusion: Rofecoxib 50mg taken prior to a twenty five hour ritual fast prevents and attenuates fasting headache.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SHEBA-04-3395-MD-CTIL |
Study First Received: | December 6, 2005 |
Last Updated: | January 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00263094 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Fasting Headache Cox 2 Inhibitors Pain Prophylaxis |
Signs and Symptoms Headache Rofecoxib Neurologic Manifestations Pain |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Cyclooxygenase 2 Inhibitors Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |