NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05761574

CompletedPhase 3

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Conditions: Pain

Interventions: Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium, Acetaminophen, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 16 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Salt Lake City, Utah, United States