NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Acetaminophen/Naproxen Sodium Dose Ranging Study

CompletedPhase 2

Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Conditions: Pain

Interventions: Acetaminophen/naproxen sodium Dose A, Acetaminophen/naproxen sodium Dose B, Acetaminophen/naproxen sodium Dose C, Acetaminophen/naproxen sodium Dose D, Acetaminophen/naproxen sodium Dose E

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 17 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Males or females 17-50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
3. Surgical removal of three or four third molars, of which, two must be mandibular impactions
4. Meets requirements for post-surgical pain level
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
3. Not able to swallow whole large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
7. Use of any immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Locations (1)

Salt Lake City, Utah, United States