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

Headache research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Headache

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:etoricoxib120 mg

Drug:placeboplacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: September 2008

Completed Date: October 2008

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Incidence of Fasting Headache

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Zev S Wimpfheimer, MD

Lead Sponsor: Shaare Zedek Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00752921

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

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