Maxi-Analgesic Phase 2 Study to Compare the Analgesic Effects in Different Dosing Groups to Treat Teeth Extraction Pain

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

Not specified

Conditions
Dental Pain
Interventions
DRUG

Full Dose Strength

Acetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets)

DRUG

Quarter dose strength

Investigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug.

DRUG

Half dose strength

Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug

DRUG

Acetaminophen standard dose

Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug

DRUG

Ibuprofen low dose

Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product

DRUG

Ibuprofen high dose

Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug

DRUG

Placebo

2 placebo tablets

Trial Locations (1)

78705

Austin Clinic, Austin

Sponsors
All Listed Sponsors
lead

AFT Pharmaceuticals, Ltd.

INDUSTRY