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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hartford Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shaare Zedek Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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