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

March 7, 2011 updated by: Hartford Hospital

Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Shaare Zedek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 -65.
  • Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
  • Patient states that he/she typically suffered from headache during fasting in the past.

Exclusion Criteria:

  • Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract
  • Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
  • Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control
  • Severe hepatic dysfunction
  • Estimated renal creatinine clearance <30 ml/min
  • History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease
  • Congestive heart failure
  • Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
  • Cancer or any other malignant disease
  • History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etoricoxib First
This arm will receive etoricoxib for six days, followed by placebo for eight days.
Drug: Placebo
Placebo
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.
Other Names:
  • arcoxia
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.
Other Names:
  • Arcoxia
Experimental: Etoricoxib Second
This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
Drug: Placebo
Placebo
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.
Other Names:
  • arcoxia
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.
Other Names:
  • Arcoxia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache
Time Frame: Two weeks
The subjects will be asked to fill out a daily 'headache diary' at the end of the fast. They will be asked if they had a headache on that day, and if so its severity. We will then compare the number of subjects having a headache on each day and total number of 'headache days' between the groups.
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Headache
Time Frame: Two weeks
We will ask the subject if they had a headache on a given day to rate its severity. We will then compare the severity of headache between groups.
Two weeks
Overall ease of fast
Time Frame: Two weeks
We will ask subjects to rate the ease of their fast on a daily basis on a 5 point scale and will compare general ease of fast between the groups.
Two weeks
Side effects and other symptoms
Time Frame: two weeks
We will ask subjects to record other symptoms or side effects they had during the fast including nausea, abdominal pain, photophobia, difficulty breathing or other.
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Collaborators

Shaare Zedek Medical Center

Investigators

  • Principal Investigator: Naim Shehadeh, MD, Rambam Health Care Campus
  • Principal Investigator: Zev Wimpfheimer, MD, Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 21, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARX_ISP_IL1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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