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

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division501 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

501

Conditions

Post-operative Dental Pain

Interventions

Test naproxen sodium tabletDRUG

Single dose of 2 test naproxen sodium 220 mg tablets

Commercial naproxen sodium tabletDRUG

Single dose of 2 naproxen sodium 220 mg tablets

Commercial naproxen sodium liquid gels capsuleDRUG

Single dose of 2 naproxen sodium 220 mg liquid gel capsules

Eligibility

Sex: ALLMin age: 17 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 17 - 50 years old 2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening 3. Dental extraction of three or four third molars 4. Meets post-surgical pain 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 be 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, 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 endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years

Locations (1)

JBR Clinical Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Time to Confirmed Perceptible Pain Relief

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.

Time frame: 12 hours

Secondary Outcomes

Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments

Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.

Time frame: Up to 45 minutes after dosing

Data from ClinicalTrials.gov

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