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

• Status: Unknown status
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Etoricoxib

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.