Ibuprofen Extended-Release Dental Pain Study

PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
PainPost-Operative PainThird Molar Extraction
Interventions
DRUG

Ibuprofen 600 mg Extended-Release Tablets

Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

DRUG

Placebo

Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Trial Locations (1)

84124

Jean Brown Research, Salt Lake City

Sponsors
All Listed Sponsors
collaborator

AAIPharma

INDUSTRY

collaborator

Jean Brown Research

OTHER

lead

SCOLR Pharma, Inc.

INDUSTRY