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Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00752921
Recruitment Status : Unknown
Verified September 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2008
Last Update Posted : September 16, 2008
Information provided by:
Shaare Zedek Medical Center

Brief Summary:

Headache during fasting is a known entity in the scientific literature. The prevalence of such a headache is high and in a study conducted in Israel was found in 60% of people with a previous predilection for headache. A prior study showed a significant decrease in the incidence of fasting headache using rofecoxib, but the drug has been taken off the market. The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced headache. The study will be a prospective double blind placebo controlled trial using adult volunteers with a history of a fasting headache who will be abstaining from food and drink on Yom Kippur.

The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease the incidence of fasting headache.

Condition or disease Intervention/treatment Phase
Headache Drug: etoricoxib Drug: placebo Phase 4

Detailed Description:

Fasting is a known trigger for headache. More specifically, headache associated with ritual fasting in compliance with religious edict has been documented and described in the literature. These have been described in Jewish and Muslim ritual fasts, and have been dubbed 'Yom Kippur headache,' and 'First of Ramadan headache' respectively. The incidence of fasting associated headache during the 25 hour fast of Yom Kippur (YK) wherein no food or drink is ingested, has been documented in approximately 40% of participants, but as high as 66% of those prone to headache. (1) A recent study was published in which the authors were able to show a marked reduction in YK headache using rofecoxib 50mg, a Cox 2 specific nonsteroidal anti-inflammatory medication with a relatively long (17 hour) half life. In a placebo controlled double blind randomized trial, in a population with a history of fasting headache, the drug was ingested just prior to the start of the fast. The placebo group had an incidence of headache 65% of the time whereas the treatment group had an incidence of 19%. Headache in the treatment set was also on average milder than in the controls. These results were all significant statistically. (3)

Unfortunately for sufferers of fasting headache, rofecoxib (Vioxx), has been removed from the market and is no longer available.

We therefore propose to conduct a second study using etoricoxib (Arcoxia) - a Cox 2 specific antiinflammatory medication with a longer half life than rofecoxib.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
Study Start Date : September 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: A
Healthy Patients, age 18-65, who typically suffer from a Headache while fasting
Drug: etoricoxib
120 mg

Placebo Comparator: B
Healthy Patients, age 18-65, who typically suffer from a Headache while fasting
Drug: placebo

Primary Outcome Measures :
  1. Incidence of Fasting Headache [ Time Frame: 25 hours after administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18 -65.
  • Patients will be enrolled if they declared that they intended to complete the 25 hour YK fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
  • We will only enroll patients who stated that they typically suffered from headache during the fast.

Exclusion Criteria:

  • Patients with chronic medical problems including:

    • Heart disease,
    • Kidney disease,
    • Liver disease,
    • Peptic ulcer disease,
    • Hypertension,
    • Diabetes,
    • Lung disease including asthma,
    • History of gastrointestinal bleeding,
    • Patients with allergies or intolerance in the past to NSAIDs,
    • Pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00752921

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Contact: Zev S Wimpfheimer, MD 972 50 868 5466

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Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Contact: Zev S Wimpfheimer, MD    972 50 868 5466   
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Zev S Wimpfheimer, MD Shaare Zedek Medical Center, Jerusalem Israel

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zev Wimpfheimer MD, Shaare Zedek Medical Center, Jerusalem Israel Identifier: NCT00752921    
Other Study ID Numbers: 54661.ctil
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008
Keywords provided by Shaare Zedek Medical Center:
Etoricoxib, Fasting Headache, Headache, Yom Kippur
Additional relevant MeSH terms:
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Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action