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



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:17 - 50
Updated:3/30/2019
Start Date:August 13, 2018
End Date:May 10, 2019
Contact:Pamela Sullivan
Email:psulliv9@its.jnj.com
Phone:215-273-8321

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A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain

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.

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
We found this trial at
1
site
1045 East 3900 South
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
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