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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148303
• Other study ID #: ARX_ISP_IL1001
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2010
• Last updated: March 7, 2011
• Start date: July 2010
• Est. completion date: August 2010

Study information

• Verified date: March 2011
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fasting
• Fasting Headache
• Headache
• Ramadan Headache

Intervention

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.
• 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.
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hartford Hospital	Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Awada A, al Jumah M. The first-of-Ramadan headache. Headache. 1999 Jul-Aug;39(7):490-3. — View 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. — View Citation

Drescher MJ, Elstein Y. Prophylactic COX 2 inhibitor: an end to the Yom Kippur headache. Headache. 2006 Nov-Dec;46(10):1487-91. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two weeks	No
Secondary	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.	Two weeks	No
Secondary	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.	Two weeks	No
Secondary	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.	two weeks	No