Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263094
Status:
COMPLETED
Last Update Posted:
2006-01-27
First Post:
2005-12-06
Brief Title:
An End to the Yom Kippur and Ramadan Headache
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 n53 ten or 189 vs 34 or 654 of the placebo group n52 had headache at some point during the fast p0001 Severity of headache in the treatment group was significantly less for the treatment group 345 vs 629 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
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 n53 ten or 189 vs 34 or 654 of the placebo group n52 had headache at some point during the fast p0001 Severity of headache in the treatment group was significantly less for the treatment group 345 vs 629 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None