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.
|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|
- 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.
- 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.
|Study Start Date:||July 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Etoricoxib First
This arm will receive etoricoxib for six days, followed by placebo for eight days.
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: arcoxiaDrug: Placebo
Experimental: Etoricoxib Second
This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.
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: ArcoxiaDrug: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148303
|Shaare Zedek Medical Center|
|Principal Investigator:||Naim Shehadeh, MD||Rambam Health Care Campus|
|Principal Investigator:||Zev Wimpfheimer, MD||Shaare Zedek Medical Center|