Acetaminophen/Naproxen Sodium Dose Ranging Study
Completed · Phase 2 · Has a placebo group
Conditions studied: Pain
In brief
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Key facts
- Study ID
- NCT04447040
- Run by
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- People needed
- 304
- Starts
- 2020-11-09
- Expected to finish
- 2021-05-03
- Last updated by the study team
- 2025-03-24
Who can join
Age: 17 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (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
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 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 of any immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Where it is running
- JBR Clinical Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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