NCT00263094

Brief Summary

Fasting is a known trigger for headache. People who fast to comply with religious edict have been shown to be prone to headache which becomes more likely to occur with increasing length of fasting, and in people prone to headache. This has been documented as 'Yom Kippur Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would prevent or attenuate headache when taken just prior to the complete (no food or drink) 25 hour fast of Yom Kippur.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2005

Completed
Last Updated

January 27, 2006

Status Verified

January 1, 2006

First QC Date

December 6, 2005

Last Update Submit

January 25, 2006

Conditions

Headache

Keywords

FastingHeadacheCox 2 InhibitorsPainProphylaxis

Outcome Measures

Primary Outcomes (1)

  • Reduction in incidence of headache during fast in treatment group versus control group

Secondary Outcomes (2)

  • Reduction in severity of headache in treatment versus control groups.

  • General ease of fast in treatment vs control groups

Interventions

RofecoxibDRUG

Eligibility Criteria

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

You may qualify if:

  • History of fasting headache
  • Age 18-65
  • Intention to fast on Yom Kippur
  • History of Fasting on Yom Kippur

You may not qualify if:

  • Pregnant or Nursing Women
  • Known allergy to NSAID type medication
  • History of chronic illness including heart, kidney, liver or peptic ulcer disease, hypertension, diabetes, lung disease including asthma, or a history of gastrointestinal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (3)

  • 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

  • Von Seggern RL, Mannix LK, Adelman JU. Rofecoxib in the prevention of perimenstrual migraine: an open-label pilot trial. Headache. 2004 Feb;44(2):160-5. doi: 10.1111/j.1526-4610.2004.04033.x.

    PMID: 14756855BACKGROUND

MeSH Terms

Conditions

HeadacheFastingPain

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Michael J Drescher, MD

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 6, 2005

First Posted

December 7, 2005

Study Start

September 1, 2004

Study Completion

November 1, 2004

Last Updated

January 27, 2006

Record last verified: 2006-01

Locations

IL(1)