A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Placebo; Drug: Acetaminophen; Drug: Naproxen Sodium; Drug: Acetaminophen/Naproxen Sodium Fixed Combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT05761574

CCSPAA005199 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Full description

This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.

Enrollment: 447 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
• Surgical removal of three or four third molars, of which, two must be mandibular impactions
• Meets requirements for post-surgical pain level
• 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 become 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, oxycodone or other opioids
• Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
• Use any immunosuppressive drugs within 2 weeks of surgical procedure
• History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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447 participants in 4 patient groups, including a placebo group

Acetaminophen/Naproxen Sodium Fixed Combination

Experimental group

Description:

Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.

Treatment:

Drug: Acetaminophen/Naproxen Sodium Fixed Combination

Naproxen Sodium

Active Comparator group

Description:

Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.

Treatment:

Drug: Naproxen Sodium

Drug: Placebo

Acetaminophen

Active Comparator group

Description:

Participants will receive a single oral dose of two Acetaminophen tablets.

Treatment:

Drug: Acetaminophen

Placebo

Placebo Comparator group

Description:

Participants will receive a single oral dose of two Placebo capsules.

Treatment:

Drug: Placebo