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HeadachePhase 4NCT01148303

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

A Phase 4 study testing Etoricoxib in people with Headache and Fasting, run by Hartford Hospital at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Headache, Fasting, Fasting Headache
What is being tested?
Etoricoxib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteIsrael
Study dates
Jul 2010to Aug 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Shaare Zedek Medical Center

    Jerusalem

Other trials in Israel

About this study

Official title: 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.

Being tested
Etoricoxib, Placebo
Keywords
Headache, Fasting, Fasting Headache, Ramadan, Ramadan Headache, Yom Kippur, Yom Kippur Headache
Medical subject headings
Headache, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtoricoxibDrug

    Also called arcoxia

    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.

  • EtoricoxibDrug

    Also called Arcoxia

    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.

  • PlaceboDrug

    Placebo

Study groups in NCT01148303
Study groupRoleWhat they receive
Etoricoxib FirstExperimentalThis arm will receive etoricoxib for six days, followed by placebo for eight days.
Receives: Drug: Etoricoxib; Drug: Placebo
Etoricoxib SecondExperimentalThis arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
Receives: Drug: Etoricoxib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache

    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.

    Measured: Two weeks

Secondary outcomes (3)

  1. Severity of Headache

    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.

    Measured: Two weeks

  2. Overall ease of fast

    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.

    Measured: Two weeks

  3. Side effects and other symptoms

    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.

    Measured: two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01148303
Sponsor's protocol ID
ARX_ISP_IL1001
Status last verified
Mar 2011
First submitted
17 Jun 2010
Last updated
8 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17115981

  • 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.

    PubMed 20039959

  • Topacoglu H, Karcioglu O, Yuruktumen A, Kiran S, Cimrin AH, Ozucelik DN, Sarikaya S, Soysal S, Turpcu U, Bozkurt S. Impact of Ramadan on demographics and frequencies of disease-related visits in the emergency department. Int J Clin Pract. 2005 Aug;59(8):900-5. doi: 10.1111/j.1742-1241.2005.00460.x.

    PubMed 16033610

  • 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.

    PubMed 11279933

  • Shah PA, Nafee A. Clinical profile of headache and cranial neuralgias. J Assoc Physicians India. 1999 Nov;47(11):1072-5.

    PubMed 10862316

  • Drescher MJ, Wimpfheimer Z, Abu Khalef S, Gammaitoni A, Shehadeh N, Torgovicky R. Prophylactic etoricoxib is effective in preventing "first of Ramadan" headache: a placebo-controlled double-blind and randomized trial of prophylactic etoricoxib for ritual fasting headache. Headache. 2012 Apr;52(4):573-81. doi: 10.1111/j.1526-4610.2011.01993.x. Epub 2011 Aug 16.

    PubMed 21848948

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Etoricoxib in people with Headache and Fasting, run by Hartford Hospital at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache (time frame: Two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01148303, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.

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