An End to the Yom Kippur (and Ramadan) Headache

January 25, 2006 updated by: Sheba Medical Center

: An End to the Yom Kippur (and Ramadan) Headache: A Double Blind Placebo Controlled Trial of Prophylactic Rofecoxib in Preventing Ritual Fasting Headache.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction in incidence of headache during fast in treatment group versus control group

Secondary Outcome Measures

Outcome Measure
Reduction in severity of headache in treatment versus control groups.
General ease of fast in treatment vs control groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Michael J Drescher, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 27, 2006

Last Update Submitted That Met QC Criteria

January 25, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-04-3395-MD-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Headache

Clinical Trials on Rofecoxib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe