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Completed

NCT Number: NCT01148303

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

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.

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Key information

Conditions

Headache Behavior Fasting Fasting Headache Feeding Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Ramadan Headache Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: arcoxia

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Shaare Zedek Medical Center

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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