HeadacheNCT00263094
An End to the Yom Kippur (and Ramadan) Headache
A study testing Rofecoxib in people with Headache, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Rofecoxib
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2004to Nov 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of fasting headache
- Age 18-65
- Intention to fast on Yom Kippur
- History of Fasting on Yom Kippur
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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.
- Conditions
- Headache
- Being tested
- Rofecoxib
- Keywords
- Fasting, Headache, Cox 2 Inhibitors, Pain, Prophylaxis
- Medical subject headings
- Headache, Fasting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RofecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in incidence of headache during fast in treatment group versus control group
Secondary outcomes (2)
Reduction in severity of headache in treatment versus control groups.
General ease of fast in treatment vs control groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startSep 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Michael J Drescher, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263094
- Sponsor's protocol ID
- SHEBA-04-3395-MD-CTIL
- Status last verified
- Jan 2006
- First submitted
- 6 Dec 2005
- Last updated
- 27 Jan 2006
- Results posted
- No
Publications
Mosek A, Korczyn AD. Yom Kippur headache. Neurology. 1995 Nov;45(11):1953-5. doi: 10.1212/wnl.45.11.1953.
PubMed 7501139Awada 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.
PubMed 11279933Von 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.
PubMed 14756855
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00263094
- Acronym / sponsor ID
- SHEBA-04-3395-MD-CTIL
- Conditions
- Headache
- Keywords
- Fasting, Headache, Cox 2 Inhibitors, Pain, Prophylaxis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2004
- Study completion
- Nov 2004
- First posted
- 7 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of fasting headache
- Age 18-65
- Intention to fast on Yom Kippur
- History of Fasting on Yom Kippur
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rofecoxib | Drug | – |
Primary outcome
Reduction in incidence of headache during fast in treatment group versus control group
2 secondary outcomes
Reduction in severity of headache in treatment versus control groups.
General ease of fast in treatment vs control groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2006.
- Background: PubMed 7501139Mosek A, Korczyn AD. Yom Kippur headache. Neurology. 1995 Nov;45(11):1953-5. doi: 10.1212/wnl.45.11.1953.
- Background: PubMed 11279933Awada 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.
- Background: PubMed 14756855Von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Drescher, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rofecoxib in people with Headache, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in incidence of headache during fast in treatment group versus control group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263094, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2006.