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

McNeil-PPC

Status and phase: Completed; Phase 3

Conditions: Post-operative Dental Pain

Treatments: Drug: Commercial naproxen sodium liquid gels capsule; Drug: Commercial naproxen sodium tablet; Drug: Placebo tablet; Drug: Test naproxen sodium tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03566979

CCSPAA000457

Details and patient eligibility

About

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.

Full 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.

Enrollment: 501 patients

Sex: All

Ages: 17 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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501 participants in 4 patient groups, including a placebo group

Test naproxen sodium tablet

Experimental group

Description:

Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX)

Treatment:

Drug: Test naproxen sodium tablet

Commercial naproxen sodium tablet

Active Comparator group

Description:

Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets

Treatment:

Drug: Commercial naproxen sodium tablet

Commercial naproxen sodium liquid gels capsule

Active Comparator group

Description:

Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules

Treatment:

Drug: Commercial naproxen sodium liquid gels capsule

Placebo tablet

Placebo Comparator group

Description:

Single dose of two Placebo tablets

Treatment:

Drug: Placebo tablet