Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Pain
In brief
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
Key facts
- Study ID
- NCT03879408
- Run by
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- People needed
- 290
- Starts
- 2019-05-28
- Expected to finish
- 2019-11-13
- Last updated by the study team
- 2022-12-05
Who can join
Age: 17 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males of females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
- Surgical removal of up to 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
You may not qualify if…
- Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
- Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids
- Not able to swallow 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, substance abuse as judged by investigator site staff within last 5 years
- Use of immunosuppressive drugs within 2 weeks of screening
- History of peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding
Where it is running
- Jean Brown Research Clinical Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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