Overview

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

Status:
Completed

Trial end date:
2019-11-13

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Treatments:

Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Naproxen

Criteria

Inclusion Criteria:

1. Males of females 17-50 years old

2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive)
at screening

3. Surgical removal of up to 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 known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin,
or to acetaminophen, tramadol, hydrocodone or other opioids

3. Not able to swallow 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, substance abuse as judged by
investigator site staff within last 5 years

7. Use of immunosuppressive drugs within 2 weeks of screening

8. History of peptic ulcer disease or gastrointestinal bleeding in the last two years or
hematologic bleeding