Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

May 30, 2026

Primary Completion Date

October 30, 2027

Study Completion Date

February 28, 2028

Conditions
Third Molar Extraction
Interventions
DRUG

FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo

Participants randomized to this group will receive one (01) capsule of the investigational drug and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.

DRUG

etoricoxib 90 mg (Arcoxia®) +FDC placebo

Participants randomized to this group will receive one (01) etoricoxib 90 mg tablet (Arcoxia®) and one (01) FDC placebo capsule, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.

DRUG

cyclobenzaprine hydrochloride + etoricoxib placebo

Participants randomized to this group will receive one (01) cyclobenzaprine hydrochloride 15 mg capsule (XL - Mitrul®) and one (01) etoricoxib placebo tablet, respecting a minimum interval of twenty-four (24) hours between doses for 3 days.

Trial Locations (1)

06696-000

Eurofarma Laboratorios S.A, São Paulo

Sponsors
All Listed Sponsors
lead

Eurofarma Laboratorios S.A.

INDUSTRY