A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

• Status: Not yet recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Treatments: Acetaminophen; Naproxen

Criteria

Inclusion Criteria:

• Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening

• Surgical removal of three or four third molars, of which, two must be mandibular impactions

• Meets requirements for post-surgical pain level

• Females of childbearing potential and males agree to contraceptive requirements of study

• Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

• Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant

• Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids

• Not able to swallow whole large tablets or capsules

• History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study

• Use analgesics 5 or more times per week

• History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years

• Use any immunosuppressive drugs within 2 weeks of surgical procedure

• History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years