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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01148303
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : March 8, 2011
Shaare Zedek Medical Center
Information provided by:
Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Headache Fasting Fasting Headache Ramadan Headache Drug: Etoricoxib Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
Study Start Date : July 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Etoricoxib First
This arm will receive etoricoxib for six days, followed by placebo for eight days.
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 Name: arcoxia

Drug: Placebo

Experimental: Etoricoxib Second
This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
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 Name: Arcoxia

Drug: Placebo

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01148303

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Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Hartford Hospital
Shaare Zedek Medical Center
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Principal Investigator: Naim Shehadeh, MD Rambam Health Care Campus
Principal Investigator: Zev Wimpfheimer, MD Shaare Zedek Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michael J Drescher MD, Hartford Hospital Identifier: NCT01148303    
Other Study ID Numbers: ARX_ISP_IL1001
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011
Keywords provided by Hartford Hospital:
Fasting Headache
Ramadan Headache
Yom Kippur
Yom Kippur Headache
Additional relevant MeSH terms:
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Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action