CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 220 enrolled
Drug / intervention
Etoricoxib +2 moredrug
Likely dose
Etoricoxib 90mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01148303
NCT01148303Phase 4Completed

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

Hartford Hospital·interventional·Posted Jun 22, 2010·Updated Mar 8, 2011

In Brief

A Phase 4 clinical trial evaluating Etoricoxib and Placebo for Headache and 3 related conditions. Completed, enrolled 220 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.0 years ago

Interventions

Etoricoxibdrug

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.

Etoricoxibdrug

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.

Placebodrug

Placebo