Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed

PHASE4CompletedINTERVENTIONAL

Enrollment

221

Participants

Timeline

Start Date

March 12, 2020

Primary Completion Date

October 2, 2020

Study Completion Date

October 5, 2020

Conditions

Pain

Interventions

DRUG

Naproxen Sodium (Aleve, BAY117031)

220 mg per tablet, two tablets (440 mg), intake a single dose orally.

DRUG

Hydrocodone/Acetaminophen

5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.

DRUG

Placebo

two tablets, intake a single dose orally.

Trial Locations (1)

JBR Clinical Research, Salt Lake City