Pain
Conditions
Keywords
Analgesics, Dental Pain, Acetaminophen, Naproxen Sodium, Pain, Fixed-Dose
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.
Interventions
Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
DRUGNaproxen Sodium
Naproxen Sodium will be administered orally.
DRUGAcetaminophen
Acetaminophen will be administered orally.
DRUGPlacebo
Placebo will be administered orally.
Sponsors
Johnson & Johnson Consumer Inc. (J&JCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Post-operative dental pain following third molar extraction.
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed