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

NCT ID: NCT00752921

Last Updated: 2008-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-10-31

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.

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.

Conditions

Headache

Keywords

Etoricoxib, Fasting Headache, Headache, Yom Kippur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

A

Healthy Patients, age 18-65, who typically suffer from a Headache while fasting

Group Type: ACTIVE_COMPARATOR

etoricoxib

Intervention Type: DRUG

120 mg

B

Healthy Patients, age 18-65, who typically suffer from a Headache while fasting

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

etoricoxib

120 mg

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Shaare Zedek Medical Center, Jerusalem Israel

Principal Investigators

Zev S Wimpfheimer, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem Israel

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Central Contacts

Zev S Wimpfheimer, MD

Role: CONTACT

Phone: 972 50 868 5466

Email: zevw@hotmail.com

Facility Contacts

Zev S Wimpfheimer, MD

Role: primary

References

Drescher MJ, Elstein Y. Prophylactic COX 2 inhibitor: an end to the Yom Kippur headache. Headache. 2006 Nov-Dec;46(10):1487-91. doi: 10.1111/j.1526-4610.2006.00609.x.

Reference Type: BACKGROUND

PMID: 17115981 (View on PubMed)

Mosek A, Korczyn AD. Yom Kippur headache. Neurology. 1995 Nov;45(11):1953-5. doi: 10.1212/wnl.45.11.1953.

Reference Type: BACKGROUND

PMID: 7501139 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11279933 (View on PubMed)

Drescher MJ, Alpert EA, Zalut T, Torgovicky R, Wimpfheimer Z. Prophylactic etoricoxib is effective in preventing Yom Kippur headache: a placebo-controlled double-blind and randomized trial of prophylaxis for ritual fasting headache. Headache. 2010 Sep;50(8):1328-34. doi: 10.1111/j.1526-4610.2009.01587.x. Epub 2009 Dec 21.

Reference Type: DERIVED

PMID: 20039959 (View on PubMed)

Other Identifiers

54661.ctil

Identifier Type: -

Identifier Source: org_study_id