Clinical trial NCT01148303: Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
Official title: Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Fasting
Fasting Headache
Ramadan Headache
Keywords: Headache
Fasting
Fasting Headache
Ramadan
Ramadan Headache
Yom Kippur
Yom Kippur Headache
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
First posted: 2010-06-22
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Headache
timeFrame: Two weeks
Secondary outcomes:
measure: Severity of Headache
timeFrame: Two weeks
measure: Overall ease of fast
timeFrame: Two weeks
measure: Side effects and other symptoms
timeFrame: two weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Naim Shehadeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: Zev Wimpfheimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Shah PA, Nafee A. Clinical profile of headache and cranial neuralgias. J Assoc Physicians India. 1999 Nov;47(11):1072-5.
citation: 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.