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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00752921
First received: September 15, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Headache
Drug: etoricoxib
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Incidence of Fasting Headache [ Time Frame: 25 hours after administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752921

Contacts
Contact: Zev S Wimpfheimer, MD 972 50 868 5466 zevw@hotmail.com

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Zev S Wimpfheimer, MD    972 50 868 5466    zevw@hotmail.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Zev S Wimpfheimer, MD Shaare Zedek Medical Center, Jerusalem Israel
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zev Wimpfheimer MD, Shaare Zedek Medical Center, Jerusalem Israel
ClinicalTrials.gov Identifier: NCT00752921     History of Changes
Other Study ID Numbers: 54661.ctil
Study First Received: September 15, 2008
Last Updated: September 15, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
Etoricoxib, Fasting Headache, Headache, Yom Kippur

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 22, 2014