Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
|ClinicalTrials.gov Identifier: NCT01148303|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : March 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Headache Fasting Fasting Headache Ramadan Headache||Drug: Etoricoxib Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||220 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache|
|Study Start Date :||July 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2010|
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
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148303
|Shaare Zedek Medical Center|
|Principal Investigator:||Naim Shehadeh, MD||Rambam Health Care Campus|
|Principal Investigator:||Zev Wimpfheimer, MD||Shaare Zedek Medical Center|