Clinical trial NCT05761574: A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
Official title: A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Analgesics
Dental Pain
Acetaminophen
Naproxen Sodium
Pain
Fixed-Dose
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 447
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-operative dental pain following third molar extraction.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)
timeFrame: 0 to 12 hours
Secondary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
timeFrame: 6 to 12 hours
measure: Time to First Request of Rescue Analgesic
timeFrame: 0 to 24 hours
measure: Percentage of Participants who Request Rescue Analgesic During the First 12 hours
timeFrame: 0 to 12 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: JBR Clinical Research LLC
state: Utah
Study officials:
affiliation: JBR Clinical Research
name: Todd Bertoch
role: PRINCIPAL_INVESTIGATOR
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