Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

Phase 3

Completed

Interventions: Drug: Test naproxen sodium tablet
Drug: Commercial naproxen sodium tablet
Drug: Placebo tablet
Drug: Commercial naproxen sodium liquid gels capsule

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

Brief Summary: To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Detailed Description: This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Recruitment & Eligibility

Inclusion Criteria

17 - 50 years old
Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
Dental extraction of three or four third molars
Meets post-surgical pain
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

Exclusion Criteria

Pregnant female, breastfeeding, trying to be 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, 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 endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years

Arm && Interventions

Group	Intervention	Description
Test naproxen sodium tablet	Test naproxen sodium tablet	Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)
Commercial naproxen sodium tablet	Commercial naproxen sodium tablet	Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets
Placebo tablet	Placebo tablet	Single dose of two Placebo tablets
Commercial naproxen sodium liquid gels capsule	Commercial naproxen sodium liquid gels capsule	Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules

Primary Outcome Measures

Name	Time	Method
Time to Confirmed Perceptible Pain Relief	12 hours	Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments	Up to 45 minutes after dosing	Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.