NCT00752921

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

1 month

First QC Date

September 15, 2008

Last Update Submit

September 15, 2008

Conditions

Headache

Keywords

Etoricoxib, Fasting Headache, Headache, Yom Kippur

Outcome Measures

Primary Outcomes (1)

  • Incidence of Fasting Headache

    25 hours after administration

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: etoricoxib

B

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

etoricoxibDRUG

120 mg

A
placeboDRUG

placebo

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (4)

  • 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.

    PMID: 17115981BACKGROUND

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

    PMID: 7501139BACKGROUND

  • 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.

    PMID: 11279933BACKGROUND

  • 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.

    PMID: 20039959DERIVED

MeSH Terms

Conditions

Headache

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zev S Wimpfheimer, MD

    Shaare Zedek Medical Center, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zev S Wimpfheimer, MD

CONTACT

972 50 868 5466zevw@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

IL(1)