Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars

PHASE3CompletedINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

April 29, 2019

Primary Completion Date

February 20, 2020

Study Completion Date

February 28, 2020

Conditions
Pain
Interventions
DRUG

Ibuprofen 300 mg Oral Tablet

2 × 300 mg tablets at Hours 0 and 12

DRUG

Ibuprofen 200 mg Oral Tablet

2 × 200 mg tablets at Hours 0, 8, and 16

DRUG

Placebo of PR tablet

2 tablets up to four times in 24 hours

DRUG

Placebo of IR tablet

2 tablets up to four times in 24 hours

Trial Locations (1)

84107

JBR Clinical Research, Salt Lake City

Sponsors
All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

NCT03785756 - Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars | Biotech Hunter | Biotech Hunter