Pain
Conditions
Keywords
Analgesics, Dental Pain, Naproxen, Acetaminophen, Pain
Brief summary
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
Detailed description
This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.
Interventions
DRUG440 mg naproxen sodium with 1000 mg acetaminophen
440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
DRUG220 mg naproxen sodium with 650 mg acetaminophen
220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
DRUG10 mg hydrocodone + 650 mg acetaminophen
10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
DRUG440 mg naproxen sodium
440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
DRUGPlacebo tablet
Single dose of four 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. Males of females 17-50 years old 2. Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening 3. Surgical removal of up to four third molars, of which, two must be mandibular impactions 4. Meets requirements for post -surgical pain level 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 become pregnant or male with pregnant partner or partner currently trying to become pregnant 2. Have known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, 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 peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | Baseline (0 hour) up to 6 hours post-dose | Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours. |
| Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | Baseline (0 hour) up to 12 hours post-dose | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | Baseline (0 hour) up to 12 hours post-dose | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief. |
| Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | Baseline (0 hour) up to 8 hours post-dose | Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours. |
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | Baseline (0 hour) up to 6 hours post-dose | Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief. |
| Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours | Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration. |
| Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | Up to 12 hours | Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome. |
| Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours | Participants answered a question at individual time points: how much relief do you have from your starting pain? on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain. |
| Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | Baseline (0 hour) up to 8 hours post-dose | TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Placebo Participants received a single oral dose of four placebo tablets at baseline (Day of surgery-Day 1). | 35 |
| Arm 2: Naproxen Sodium 440 mg Participants received a single oral dose of naproxen sodium 440 milligrams (mg)(administered as two naproxen sodium 220 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). | 69 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg Participants received a single oral dose of naproxen sodium 220 mg tablet (administered as one naproxen sodium 220 mg tablet) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and one placebo tablet at baseline (Day of surgery-Day 1). | 61 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg Participants received a single oral dose of naproxen sodium 440 mg (administered as two naproxen sodium 220 mg tablets) and acetaminophen 1000 mg (two acetaminophen 500 mg tablets) at baseline (Day of surgery-Day 1). | 63 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg Participants received a single oral dose of hydrocodone 10 mg (administered as two hydrocodone 5 mg tablets) and acetaminophen 650 mg (two acetaminophen 325 mg tablets) and two placebo tablets at baseline (Day of surgery-Day 1). | 62 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 1: Placebo | Arm 2: Naproxen Sodium 440 mg | Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 18.4 years STANDARD_DEVIATION 1.5 | 19.0 years STANDARD_DEVIATION 2.39 | 18.2 years STANDARD_DEVIATION 1.33 | 19.0 years STANDARD_DEVIATION 2.23 | 18.3 years STANDARD_DEVIATION 1.7 | 18.6 years STANDARD_DEVIATION 1.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 5 Participants | 6 Participants | 6 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 60 Participants | 56 Participants | 57 Participants | 56 Participants | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 32 Participants | 61 Participants | 57 Participants | 54 Participants | 57 Participants | 261 Participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 33 Participants | 35 Participants | 32 Participants | 155 Participants |
| Sex: Female, Male Male | 16 Participants | 33 Participants | 28 Participants | 28 Participants | 30 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 69 | 0 / 61 | 0 / 63 | 0 / 62 |
| other Total, other adverse events | 14 / 35 | 5 / 69 | 8 / 61 | 9 / 63 | 22 / 62 |
| serious Total, serious adverse events | 0 / 35 | 0 / 69 | 0 / 61 | 0 / 63 | 0 / 62 |
Outcome results
Primary
Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours.
Time frame: Baseline (0 hour) up to 12 hours post-dose
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | 5.80 Units on a scale | Standard Error 4.666 |
| Arm 2: Naproxen Sodium 440 mg | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | 50.07 Units on a scale | Standard Error 3.341 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | 55.47 Units on a scale | Standard Error 3.587 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | 66.43 Units on a scale | Standard Error 3.494 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) | 39.94 Units on a scale | Standard Error 3.533 |
Primary
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)
Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours.
Time frame: Baseline (0 hour) up to 6 hours post-dose
Population: Intent-to-Treat (ITT) analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | 2.36 Units on a scale | Standard Error 2.181 |
| Arm 2: Naproxen Sodium 440 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | 25.59 Units on a scale | Standard Error 1.562 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | 30.28 Units on a scale | Standard Error 1.677 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | 33.77 Units on a scale | Standard Error 1.633 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) | 23.60 Units on a scale | Standard Error 1.651 |
Secondary
Pain Intensity Difference (PID) Scores at Individual Time Points
Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration.
Time frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 7 Hours | 0.40 Units on a scale | Standard Error 0.45 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.5 Hours | 0.31 Units on a scale | Standard Error 0.39 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours | 0.25 Units on a scale | Standard Error 0.21 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 11 Hours | 0.69 Units on a scale | Standard Error 0.5 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 5 Hours | 0.50 Units on a scale | Standard Error 0.44 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.25 Hours | 0.34 Units on a scale | Standard Error 0.4 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 4 Hours | 0.53 Units on a scale | Standard Error 0.43 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.5 Hours | 0.07 Units on a scale | Standard Error 0.33 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.75 Hours | 0.24 Units on a scale | Standard Error 0.38 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 10 Hours | 0.64 Units on a scale | Standard Error 0.4 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 8 Hours | 0.48 Units on a scale | Standard Error 0.45 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 9 Hours | 0.53 Units on a scale | Standard Error 0.46 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 6 Hours | 0.47 Units on a scale | Standard Error 0.44 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 3 Hours | 0.34 Units on a scale | Standard Error 0.41 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 2 Hours | 0.22 Units on a scale | Standard Error 0.4 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 12 Hours | 0.71 Units on a scale | Standard Error 0.5 |
| Arm 1: Placebo | Pain Intensity Difference (PID) Scores at Individual Time Points | 1 Hours | 0.45 Units on a scale | Standard Error 0.39 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 3 Hours | 4.75 Units on a scale | Standard Error 0.3 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 6 Hours | 4.50 Units on a scale | Standard Error 0.32 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 7 Hours | 4.36 Units on a scale | Standard Error 0.32 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.75 Hours | 3.15 Units on a scale | Standard Error 0.27 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 8 Hours | 4.17 Units on a scale | Standard Error 0.32 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1 Hours | 3.97 Units on a scale | Standard Error 0.28 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 11 Hours | 3.99 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.25 Hours | 4.50 Units on a scale | Standard Error 0.28 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.5 Hours | 4.72 Units on a scale | Standard Error 0.28 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.5 Hours | 1.82 Units on a scale | Standard Error 0.24 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 2 Hours | 4.87 Units on a scale | Standard Error 0.28 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 10 Hours | 4.01 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours | 0.58 Units on a scale | Standard Error 0.15 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 4 Hours | 4.63 Units on a scale | Standard Error 0.31 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 12 Hours | 3.91 Units on a scale | Standard Error 0.36 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 5 Hours | 4.59 Units on a scale | Standard Error 0.32 |
| Arm 2: Naproxen Sodium 440 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 9 Hours | 4.04 Units on a scale | Standard Error 0.33 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 2 Hours | 5.49 Units on a scale | Standard Error 0.31 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.5 Hours | 2.61 Units on a scale | Standard Error 0.25 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 5 Hours | 5.51 Units on a scale | Standard Error 0.34 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.75 Hours | 3.82 Units on a scale | Standard Error 0.29 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 8 Hours | 4.74 Units on a scale | Standard Error 0.34 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 3 Hours | 5.62 Units on a scale | Standard Error 0.32 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 9 Hours | 4.46 Units on a scale | Standard Error 0.35 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 11 Hours | 3.63 Units on a scale | Standard Error 0.38 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.25 Hours | 4.87 Units on a scale | Standard Error 0.3 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 12 Hours | 3.53 Units on a scale | Standard Error 0.38 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1 Hours | 4.41 Units on a scale | Standard Error 0.3 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 7 Hours | 4.96 Units on a scale | Standard Error 0.34 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.5 Hours | 5.18 Units on a scale | Standard Error 0.3 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 6 Hours | 5.28 Units on a scale | Standard Error 0.34 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 10 Hours | 3.87 Units on a scale | Standard Error 0.37 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours | 1.01 Units on a scale | Standard Error 0.16 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 4 Hours | 5.64 Units on a scale | Standard Error 0.33 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 8 Hours | 5.68 Units on a scale | Standard Error 0.34 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours | 0.85 Units on a scale | Standard Error 0.15 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.5 Hours | 3.06 Units on a scale | Standard Error 0.25 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.75 Hours | 4.31 Units on a scale | Standard Error 0.29 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1 Hours | 4.95 Units on a scale | Standard Error 0.29 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 5 Hours | 6.13 Units on a scale | Standard Error 0.33 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.25 Hours | 5.42 Units on a scale | Standard Error 0.3 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.5 Hours | 5.76 Units on a scale | Standard Error 0.29 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 2 Hours | 6.01 Units on a scale | Standard Error 0.3 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 3 Hours | 6.17 Units on a scale | Standard Error 0.31 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 4 Hours | 6.31 Units on a scale | Standard Error 0.32 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 6 Hours | 6.06 Units on a scale | Standard Error 0.33 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 7 Hours | 5.82 Units on a scale | Standard Error 0.34 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 9 Hours | 5.41 Units on a scale | Standard Error 0.34 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 10 Hours | 5.43 Units on a scale | Standard Error 0.36 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 11 Hours | 5.16 Units on a scale | Standard Error 0.37 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 12 Hours | 5.16 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 4 Hours | 4.26 Units on a scale | Standard Error 0.33 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.5 Hours | 2.36 Units on a scale | Standard Error 0.25 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 9 Hours | 2.56 Units on a scale | Standard Error 0.35 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 3 Hours | 4.51 Units on a scale | Standard Error 0.31 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 2 Hours | 4.67 Units on a scale | Standard Error 0.3 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.5 Hours | 4.74 Units on a scale | Standard Error 0.3 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.25 hours | 00.79 Units on a scale | Standard Error 0.16 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 10 Hours | 2.42 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1.25 Hours | 4.71 Units on a scale | Standard Error 0.3 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 1 Hours | 4.48 Units on a scale | Standard Error 0.3 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 12 Hours | 2.66 Units on a scale | Standard Error 0.38 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 11 Hours | 2.71 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 0.75 Hours | 3.77 Units on a scale | Standard Error 0.29 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 7 Hours | 3.08 Units on a scale | Standard Error 0.34 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 8 Hours | 2.90 Units on a scale | Standard Error 0.34 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 6 Hours | 3.39 Units on a scale | Standard Error 0.34 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Intensity Difference (PID) Scores at Individual Time Points | 5 Hours | 3.89 Units on a scale | Standard Error 0.34 |
Secondary
Pain Relief (PAR) Scores at Individual Timepoints
Participants answered a question at individual time points: how much relief do you have from your starting pain? on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain.
Time frame: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 9 Hours | 1.61 Units on a scale | Standard Error 0.56 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 0.5 Hours | 0.51 Units on a scale | Standard Error 0.44 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 1.5 Hours | 1.18 Units on a scale | Standard Error 0.48 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours | 0.45 Units on a scale | Standard Error 0.26 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 1.25 Hours | 1.13 Units on a scale | Standard Error 0.49 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 7 Hours | 1.51 Units on a scale | Standard Error 0.55 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 0.75 Hours | 0.77 Units on a scale | Standard Error 0.48 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 11 Hours | 1.86 Units on a scale | Standard Error 0.6 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 8 Hours | 1.65 Units on a scale | Standard Error 0.54 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 6 Hours | 1.53 Units on a scale | Standard Error 0.53 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 5 Hours | 1.59 Units on a scale | Standard Error 0.52 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 1 Hours | 1.06 Units on a scale | Standard Error 0.49 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 12 Hours | 1.89 Units on a scale | Standard Error 0.61 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 10 Hours | 1.73 Units on a scale | Standard Error 0.58 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 4 Hours | 1.66 Units on a scale | Standard Error 0.51 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 3 Hours | 1.37 Units on a scale | Standard Error 0.49 |
| Arm 1: Placebo | Pain Relief (PAR) Scores at Individual Timepoints | 2 Hours | 1.08 Units on a scale | Standard Error 0.48 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 9 Hours | 5.73 Units on a scale | Standard Error 0.4 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 10 Hours | 5.71 Units on a scale | Standard Error 0.42 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 11 Hours | 5.71 Units on a scale | Standard Error 0.43 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 12 Hours | 5.62 Units on a scale | Standard Error 0.44 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1 Hours | 5.29 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.25 Hours | 5.99 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.5 Hours | 6.36 Units on a scale | Standard Error 0.34 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 2 Hours | 6.62 Units on a scale | Standard Error 0.34 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.5 Hours | 2.27 Units on a scale | Standard Error 0.31 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 3 Hours | 6.52 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 4 Hours | 1.46 Units on a scale | Standard Error 0.36 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 5 Hours | 6.45 Units on a scale | Standard Error 0.37 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours | 0.80 Units on a scale | Standard Error 0.18 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 6 Hours | 6.26 Units on a scale | Standard Error 0.38 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 7 Hours | 6.05 Units on a scale | Standard Error 0.39 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.75 Hours | 4.11 Units on a scale | Standard Error 0.35 |
| Arm 2: Naproxen Sodium 440 mg | Pain Relief (PAR) Scores at Individual Timepoints | 8 Hours | 5.95 Units on a scale | Standard Error 0.39 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 2 Hours | 7.37 Units on a scale | Standard Error 0.37 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 3 Hours | 7.61 Units on a scale | Standard Error 0.38 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.5 Hours | 3.46 Units on a scale | Standard Error 0.33 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 12 Hours | 5.18 Units on a scale | Standard Error 0.47 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 4 Hours | 7.68 Units on a scale | Standard Error 0.39 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 9 Hours | 6.27 Units on a scale | Standard Error 0.43 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 5 Hours | 7.43 Units on a scale | Standard Error 0.4 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 8 Hours | 6.63 Units on a scale | Standard Error 0.42 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 11 Hours | 5.33 Units on a scale | Standard Error 0.46 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 6 Hours | 7.23 Units on a scale | Standard Error 0.41 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours | 1.36 Units on a scale | Standard Error 0.2 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.25 Hours | 6.46 Units on a scale | Standard Error 0.38 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.75 Hours | 5.10 Units on a scale | Standard Error 0.37 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.5 Hours | 6.89 Units on a scale | Standard Error 0.37 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1 Hours | 5.91 Units on a scale | Standard Error 0.38 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 10 Hours | 5.66 Units on a scale | Standard Error 0.45 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 7 Hours | 6.80 Units on a scale | Standard Error 0.42 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours | 1.07 Units on a scale | Standard Error 0.19 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 7 Hours | 7.94 Units on a scale | Standard Error 0.41 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 12 Hours | 7.25 Units on a scale | Standard Error 0.46 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 9 Hours | 7.44 Units on a scale | Standard Error 0.42 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 8 Hours | 7.71 Units on a scale | Standard Error 0.41 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 3 Hours | 8.24 Units on a scale | Standard Error 0.37 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1 Hours | 6.60 Units on a scale | Standard Error 0.37 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 6 Hours | 8.15 Units on a scale | Standard Error 0.4 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.75 Hours | 5.71 Units on a scale | Standard Error 0.36 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.5 Hours | 7.65 Units on a scale | Standard Error 0.36 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 4 Hours | 8.46 Units on a scale | Standard Error 0.38 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.5 Hours | 4.03 Units on a scale | Standard Error 0.33 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 11 Hours | 7.26 Units on a scale | Standard Error 0.45 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 10 Hours | 7.49 Units on a scale | Standard Error 0.44 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 2 Hours | 7.97 Units on a scale | Standard Error 0.36 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 5 Hours | 8.23 Units on a scale | Standard Error 0.39 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.25 Hours | 7.17 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 12 Hours | 3.98 Units on a scale | Standard Error 0.46 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.25 hours | 1.04 Units on a scale | Standard Error 0.2 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.5 Hours | 3.23 Units on a scale | Standard Error 0.36 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 0.75 Hours | 5.08 Units on a scale | Standard Error 0.36 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1 Hours | 6.03 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.25 Hours | 6.40 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 1.5 Hours | 6.44 Units on a scale | Standard Error 0.36 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 2 Hours | 6.38 Units on a scale | Standard Error 0.36 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 3 Hours | 6.26 Units on a scale | Standard Error 0.37 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 4 Hours | 5.96 Units on a scale | Standard Error 0.38 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 5 Hours | 5.54 Units on a scale | Standard Error 0.4 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 6 Hours | 4.88 Units on a scale | Standard Error 0.4 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 7 Hours | 4.50 Units on a scale | Standard Error 0.41 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 8 Hours | 4.23 Units on a scale | Standard Error 0.41 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 9 Hours | 3.88 Units on a scale | Standard Error 0.43 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 10 Hours | 3.66 Units on a scale | Standard Error 0.44 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Pain Relief (PAR) Scores at Individual Timepoints | 11 Hours | 3.91 Units on a scale | Standard Error 0.46 |
Secondary
Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome.
Time frame: Up to 12 hours
Population: ITT analysis set included all randomized participants. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | 0.8 Units on a Scale | Standard Error 0.18 |
| Arm 2: Naproxen Sodium 440 mg | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | 2.7 Units on a Scale | Standard Error 0.13 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | 2.9 Units on a Scale | Standard Error 0.14 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | 3.3 Units on a Scale | Standard Error 0.13 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation | 2.7 Units on a Scale | Standard Error 0.14 |
Secondary
Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours.
Time frame: Baseline (0 hour) up to 8 hours post-dose
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | 3.24 Units on a scale | Standard Error 2.981 |
| Arm 2: Naproxen Sodium 440 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | 34.11 Units on a scale | Standard Error 2.134 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | 39.98 Units on a scale | Standard Error 2.291 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | 45.27 Units on a scale | Standard Error 2.232 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) | 29.58 Units on a scale | Standard Error 2.257 |
Secondary
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief.
Time frame: Baseline (0 hour) up to 12 hours post-dose
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | 18.20 Units on a scale | Standard Error 5.595 |
| Arm 2: Naproxen Sodium 440 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | 69.96 Units on a scale | Standard Error 4.006 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | 76.80 Units on a scale | Standard Error 4.301 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | 90.22 Units on a scale | Standard Error 4.19 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) | 57.03 Units on a scale | Standard Error 4.237 |
Secondary
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief.
Time frame: Baseline (0 hour) up to 6 hours post-dose
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | 7.96 Units on a scale | Standard Error 2.581 |
| Arm 2: Naproxen Sodium 440 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | 35.20 Units on a scale | Standard Error 1.848 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | 40.94 Units on a scale | Standard Error 1.984 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | 45.13 Units on a scale | Standard Error 1.933 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) | 32.88 Units on a scale | Standard Error 1.954 |
Secondary
Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief.
Time frame: Baseline (0 hour) up to 8 hours post-dose
Population: ITT analysis set included all randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Placebo | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | 11.12 Units on a scale | Standard Error 3.554 |
| Arm 2: Naproxen Sodium 440 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | 47.19 Units on a scale | Standard Error 2.545 |
| Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | 54.37 Units on a scale | Standard Error 2.732 |
| Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | 60.78 Units on a scale | Standard Error 2.662 |
| Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg | Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) | 41.61 Units on a scale | Standard Error 2.691 |