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

Phase 4

Completed

• Conditions: Headache; Fasting; Fasting Headache; Ramadan Headache
• Interventions: Drug: Etoricoxib; Drug: Placebo

• Registration Number: NCT01148303
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-21
• Study First Posted: 2010-06-22
• Study Start: 2010-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-07
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Etoricoxib First	Placebo	This arm will receive etoricoxib for six days, followed by placebo for eight days.
Etoricoxib Second	Placebo	This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
Etoricoxib First	Etoricoxib	This arm will receive etoricoxib for six days, followed by placebo for eight days.
Etoricoxib Second	Etoricoxib	This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.

Primary Outcome Measures

Name	Time	Method
Headache	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

Name	Time	Method
Severity of Headache	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.
Overall ease of fast	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.
Side effects and other symptoms	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.

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel