NCT01148303

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-06-22
• Last updated: 2011-03-08

Locations

1 site across 1 country: Israel