Post-operative Dental Pain
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGTest naproxen sodium tablet
Single dose of 2 test naproxen sodium 220 mg tablets
DRUGCommercial naproxen sodium tablet
Single dose of 2 naproxen sodium 220 mg tablets
DRUGCommercial naproxen sodium liquid gels capsule
Single dose of 2 naproxen sodium 220 mg liquid gel capsules
DRUGPlacebo tablet
2 placebo tablets
Sponsors
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Post-operative dental pain following third molar extraction.
Eligibility
Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Confirmed Perceptible Pain Relief | 12 hours | Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | Up to 45 minutes after dosing | Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Single dose of two Placebo tablets. | 58 |
| Test Naproxen Sodium 440 Milligram (mg) Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX). | 152 |
| Commercial Naproxen Sodium Tablet 440 mg Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets. | 142 |
| Commercial Naproxen Sodium Liquid Gel Capsule 440 mg Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules. | 149 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 7 | 9 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Commercial Naproxen Sodium Liquid Gel Capsule 440 mg | Commercial Naproxen Sodium Tablet 440 mg | Test Naproxen Sodium 440 Milligram (mg) |
|---|---|---|---|---|---|
| Age, Continuous | 19.1 years STANDARD_DEVIATION 2.11 | 19 years STANDARD_DEVIATION 2.26 | 19.1 years STANDARD_DEVIATION 2.3 | 18.9 years STANDARD_DEVIATION 2.34 | 18.9 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 71 Participants | 20 Participants | 20 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 428 Participants | 129 Participants | 121 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 11 Participants | 5 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 24 Participants | 5 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 51 Participants | 451 Participants | 134 Participants | 126 Participants | 140 Participants |
| Region of Enrollment United States | 58 Participants | 501 Participants | 149 Participants | 142 Participants | 152 Participants |
| Sex: Female, Male Female | 29 Participants | 262 Participants | 75 Participants | 77 Participants | 81 Participants |
| Sex: Female, Male Male | 29 Participants | 239 Participants | 74 Participants | 65 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 152 | 0 / 142 | 0 / 149 |
| other Total, other adverse events | 6 / 58 | 2 / 152 | 6 / 142 | 4 / 149 |
| serious Total, serious adverse events | 0 / 58 | 0 / 152 | 0 / 142 | 0 / 149 |
Outcome results
Primary
Time to Confirmed Perceptible Pain Relief
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.
Time frame: 12 hours
Population: Population analyzed included all randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Confirmed Perceptible Pain Relief | NA Minutes |
| Test Naproxen Sodium Tablet (440 mg) | Time to Confirmed Perceptible Pain Relief | 18.7 Minutes |
| Commercial Naproxen Sodium Tablets (440 mg) | Time to Confirmed Perceptible Pain Relief | 23.5 Minutes |
| Commercial Naproxen Sodium Liquid Gel Capsules (440 mg) | Time to Confirmed Perceptible Pain Relief | 28.1 Minutes |
Secondary
Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.
Time frame: Up to 45 minutes after dosing
Population: Population analyzed included all randomized participants. Data for this outcome measure was planned to be analyzed and reported only for Placebo and Test NPX (440 mg) arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 44 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 28 minutes after dosing | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 36 minutes after dosing | 24.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 27 minutes after dosing | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 40 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 26 minutes after dosing | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 35 minutes after dosing | 24.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 25 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 42 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 24 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 34 minutes after dosing | 24.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 23 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 39 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 22 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 33 minutes after dosing | 24.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 21 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 43 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 20 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 32 minutes after dosing | 22.4 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 19 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 38 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 18 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 31 minutes after dosing | 20.7 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 17 minutes after dosing | 17.2 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 41 minutes after dosing | 25.9 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 16 minutes after dosing | 12.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 30 minutes after dosing | 20.7 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 15 minutes after dosing | 12.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 37 minutes after dosing | 24.1 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 14 minutes after dosing | 8.6 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 29 minutes after dosing | 19.0 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 13 minutes after dosing | 8.6 Percentage of Participants |
| Placebo | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 45 minutes after dosing | 27.6 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 13 minutes after dosing | 17.1 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 45 minutes after dosing | 84.9 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 44 minutes after dosing | 84.9 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 43 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 42 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 41 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 40 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 39 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 38 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 37 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 36 minutes after dosing | 84.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 35 minutes after dosing | 83.6 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 34 minutes after dosing | 82.9 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 33 minutes after dosing | 82.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 32 minutes after dosing | 81.6 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 31 minutes after dosing | 80.3 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 30 minutes after dosing | 74.3 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 29 minutes after dosing | 71.7 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 28 minutes after dosing | 69.1 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 27 minutes after dosing | 69.1 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 26 minutes after dosing | 67.8 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 25 minutes after dosing | 67.8 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 24 minutes after dosing | 65.8 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 23 minutes after dosing | 63.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 22 minutes after dosing | 61.8 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 21 minutes after dosing | 57.9 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 20 minutes after dosing | 53.9 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 19 minutes after dosing | 50.7 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 18 minutes after dosing | 47.4 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 17 minutes after dosing | 45.4 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 16 minutes after dosing | 42.1 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 15 minutes after dosing | 32.2 Percentage of Participants |
| Test Naproxen Sodium Tablet (440 mg) | Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | 14 minutes after dosing | 23.0 Percentage of Participants |