Acetaminophen/Naproxen Sodium Dose Ranging Study

• Status: Completed
• Trial end date: 2021-05-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Treatments: Acetaminophen; Naproxen

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