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

This study has been completed.
Sponsor:
Collaborator:
Shaare Zedek Medical Center
Information provided by:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01148303
First received: June 17, 2010
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Headache
Fasting
Fasting Headache
Ramadan Headache
Drug: Etoricoxib
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Headache [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    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:
  • Severity of Headache [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    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.

  • Overall ease of fast [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    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.

  • Side effects and other symptoms [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 220
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148303

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael J Drescher MD, Hartford Hospital
ClinicalTrials.gov Identifier: NCT01148303     History of Changes
Other Study ID Numbers: ARX_ISP_IL1001
Study First Received: June 17, 2010
Last Updated: March 7, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hartford Hospital:
Headache
Fasting
Fasting Headache
Ramadan
Ramadan Headache
Yom Kippur
Yom Kippur Headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014