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

NCT01148303 | Completed Phase 4

• 1 other identifier: ARX_ISP_IL1001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Fasting; Fasting Headache; Ramadan Headache

Keywords

Headache; Fasting; Fasting Headache; Ramadan; Ramadan Headache; Yom Kippur; Yom Kippur Headache

Outcome Measures

Primary Outcomes (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.

  Two weeks

Secondary Outcomes (3)

• Severity of Headache

  Two weeks

• Overall ease of fast

  Two weeks

• Side effects and other symptoms

  two weeks

Study Arms (2)

Etoricoxib First

EXPERIMENTAL

This arm will receive etoricoxib for six days, followed by placebo for eight days.

Drug: Etoricoxib; Drug: Placebo

Etoricoxib Second

EXPERIMENTAL

This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.

Drug: Etoricoxib; Drug: Placebo

Interventions

Etoricoxib DRUG

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.

Also known as: arcoxia

Etoricoxib First

Placebo DRUG

Placebo

Etoricoxib First; Etoricoxib Second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hartford Hospital: lead
• Shaare Zedek Medical Center: collaborator

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (6)

• 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.

  PMID: 17115981 BACKGROUND

• 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.

  PMID: 20039959 BACKGROUND

• 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.

  PMID: 16033610 BACKGROUND

• 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.

  PMID: 11279933 BACKGROUND

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

  PMID: 10862316 BACKGROUND

• 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.

  PMID: 21848948 DERIVED

MeSH Terms

Conditions

Headache; Fasting

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Naim Shehadeh, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

• Zev Wimpfheimer, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

IL (1)