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Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

NCT01148303 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2011-03-08

No results posted yet for this study

Summary

The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia) taken just before the Ramadan fast will prevent or lessen headache that some people get while fasting. The investigators hypothesize that etoricoxib will reduce the number of people getting headache, more than placebo. The investigators will do this by giving participants in the study either real medication or placebo (sugar pill) and comparing the results. The investigators will study this over two weeks. The first week one group will get the medicine and the other the placebo. The second the groups will switch. Neither the subjects nor the investigators will know who is in which group.

Conditions

  • Headache
  • Fasting
  • Fasting Headache
  • Ramadan Headache

Interventions

DRUG

Etoricoxib

Subjects will take etoricoxib 90mg by mouth just before the start of the daily fast. This will be for six days. After this they will receive placebo for eight days.

DRUG

Etoricoxib

This arm will receive placebo just before their fast for eight days. After this they will receive etoricoxib 90mg just before their daily fast for the next six days.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    collaborator OTHER

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Naim Shehadeh, MD · Rambam Health Care Campus

  • Zev Wimpfheimer, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148303 on ClinicalTrials.gov