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

Phase 3

Completed

Interventions: Drug: Acetaminophen
Drug: Acetaminophen/Naproxen Sodium Fixed Combination
Drug: Naproxen Sodium
Drug: Placebo

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Naproxen Sodium	Placebo	Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Acetaminophen	Acetaminophen	Participants will receive a single oral dose of two Acetaminophen tablets.
Acetaminophen/Naproxen Sodium Fixed Combination	Acetaminophen/Naproxen Sodium Fixed Combination	Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.
Placebo	Placebo	Participants will receive a single oral dose of two Placebo capsules.
Naproxen Sodium	Naproxen Sodium	Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.

Primary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)	0 to 12 hours	Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

Secondary Outcome Measures

Name	Time	Method
Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)	6 to 12 hours	Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.
Time to First Request of Rescue Analgesic	0 to 24 hours	Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
Percentage of Participants who Request Rescue Analgesic During the First 12 hours	0 to 12 hours	Percentage of participants who request rescue analgesic during the first 12 hours will be reported.