An End to the Yom Kippur (and Ramadan) Headache
Primary Purpose
Headache
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Rofecoxib
Sponsored by
About this trial
This is an interventional prevention trial for Headache focused on measuring Fasting, Headache, Cox 2 Inhibitors, Pain, Prophylaxis
Eligibility Criteria
Inclusion Criteria: History of fasting headache Age 18-65 Intention to fast on Yom Kippur History of Fasting on Yom Kippur Exclusion Criteria: Pregnant or Nursing Women Known allergy to NSAID type medication History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding.
Sites / Locations
- Sheba Medical Center
Outcomes
Primary Outcome Measures
Reduction in incidence of headache during fast in treatment group versus control group
Secondary Outcome Measures
Reduction in severity of headache in treatment versus control groups.
General ease of fast in treatment vs control groups
Full Information
NCT ID
NCT00263094
First Posted
December 6, 2005
Last Updated
January 25, 2006
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00263094
Brief Title
An End to the Yom Kippur (and Ramadan) Headache
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
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 (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Fasting, Headache, Cox 2 Inhibitors, Pain, Prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rofecoxib
Primary Outcome Measure Information:
Title
Reduction in incidence of headache during fast in treatment group versus control group
Secondary Outcome Measure Information:
Title
Reduction in severity of headache in treatment versus control groups.
Title
General ease of fast in treatment vs control groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of fasting headache
Age 18-65
Intention to fast on Yom Kippur
History of Fasting on Yom Kippur
Exclusion Criteria:
Pregnant or Nursing Women
Known allergy to NSAID type medication
History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Drescher, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
7501139
Citation
Mosek A, Korczyn AD. Yom Kippur headache. Neurology. 1995 Nov;45(11):1953-5. doi: 10.1212/wnl.45.11.1953.
Results Reference
background
PubMed Identifier
11279933
Citation
Awada A, al Jumah M. The first-of-Ramadan headache. Headache. 1999 Jul-Aug;39(7):490-3. doi: 10.1046/j.1526-4610.1999.3907490.x.
Results Reference
background
PubMed Identifier
14756855
Citation
Von Seggern RL, Mannix LK, Adelman JU. Rofecoxib in the prevention of perimenstrual migraine: an open-label pilot trial. Headache. 2004 Feb;44(2):160-5. doi: 10.1111/j.1526-4610.2004.04033.x.
Results Reference
background
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An End to the Yom Kippur (and Ramadan) Headache
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