Dysmenorrhea
Conditions
Keywords
Primary dysmenorrhea of at least moderate severity
Brief summary
The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.
Interventions
DRUGNaproxen Sodium, (Aleve, BAY117031)
220 mg \*2 tablets, orally, single dose
500 mg \*2 caplets, orally, single dose
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory healthy female patients between 15 and 35 years of age; * Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea; * Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days; * Patient has a self-reported history of primary dysmenorrhea (onset \<5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles; * Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded; * Patient typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, acetaminophen, or ibuprofen taken on at least 1 day of her menstrual cycle for the treatment of moderate or severe menstrual cramp, and normally experiences pain relief from these medications; * Patient is of child-bearing potential and is using one of the following methods of contraception and agrees to continue this same method for the duration of the study: * Abstinence for at least the last 60 days AND willingness to use double barrier method should the patient become sexually active during the study; * Double barrier method (condom with contraceptive foam, diaphragm with contraceptive gel); * Permanent sterilization of patient or her spouse/partner; * Oral contraceptive (must have been using the same oral contraceptive for at least three months prior to study entry and agrees to remain on the same type and method throughout the course of the study). * Patient is willing to participate in the study and return to the study site within approximately 1 week after her menstrual cycle to return the study medication, urine pregnancy test, and for review of the completed patient e-diary; * Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period; * Patient is willing to abstain from caffeine consumption throughout the 12-hour Treatment Period; * Patient is willing to ingest the overencapsulated tablets throughout the study; * Patient is willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other study procedures according to the clinical protocol.
Exclusion criteria
* Patient has a known history of allergic, idiosyncratic or serious adverse reaction, to acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal anti-inflammatory drug (NSAID); * Patient has a known allergy to any of the excipients in any of the study medication products; * Patient has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, acetaminophen or other NSAIDs; * Patient has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator's judgment, contraindicates administration of the study medication; * Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration; * Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent \[defined as more than three per year\] prior history of an urinary tract infection is eligible for enrollment), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data; * Patient has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge; * Patient requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms; * Patient is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents). Patients who are on a stable dose for at least 3 months, and not taking this medication for dysmenorrhea or premenstrual syndrome are eligible for enrollment; * Patient does not agree to abstain from taking any analgesic and/or anti-inflammatory medication (with the exception of low dose aspirin \[defined as no greater than 100 mg daily\] taken for cardioprotective purposes) approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for each treatment period and throughout the dosing/assessment period; * Patient does not agree to abstain from using transcutaneous electrical nerve stimulation devices that are used to treat dysmenorrhea throughout each treatment period; * Patient is taking piroxicam (Feldene®) or oral corticosteroids. Patients taking inhaled or topical corticosteroids are eligible for enrollment; * Patient is pregnant, lactating , or less than 6 months postpartum; * Patient is currently using an intra-uterine devices (IUD), or using hormonal implants (e.g., Norplant) or injections (e.g., Depo-Provera) for contraception or used within the past 6 months; * Patient is currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study; * Patient has a history of chronic abuse of alcohol (regularly consumes 3 or more alcoholic drinks per day), analgesics, narcotic analgesics, ergot alkaloids, tranquilizers, or opioids or other substances known to produce dependence; in the judgement of the investigator within the past 3 years; * Positive drug at screening and visit 2 for illegal drug substances, or non-prescribed controlled substances; * Positive pregnancy test or breast feeding at screening and prior to dosing in each Treatment Period; * Patients with a medical disorder, condition or history such that could impair the patient's ability to participate or complete this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | Up to 12 hours post-dose | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 46. Higher scores was indicative of more pain relief. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPID Over 0-6 Hours | Up to 6 hours post-dose | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55. |
| SPID Over 6-12 Hours | From 6 hours to 12 hours post-dose | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60. |
| TOTPAR Over 0-6 Hours | Up to 6 hours post-dose | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 22. Higher scores was indicative of more pain relief. |
| TOTPAR 6-12 Hours | From 6 hours to 12 hours post-dose | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 24. Higher scores was indicative of more pain relief. |
| Summed Pain Intensity Difference (SPID) Over 0-12 Hours | Up to 12 hours post-dose | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115. |
| Pain Intensity Difference (PID) Scores at Each Evaluation | Up to 12 hours post-dose | Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. |
| Number of Participants by Global Evaluation Scores | Up to 12 hours post-dose | Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.' |
| Pain Relief Scores at Each Evaluation | Up to 12 hours post-dose | Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). |
| Time to First Intake of Rescue Medication | Up to 12 hours post-dose | Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment. |
Countries
United States
Participant flow
Recruitment details
Study was conducted at multiple centers in the US between 05 April 2018 (first patient first visit) and 05 September 2018 (last patient last visit).
Pre-assignment details
Overall, 242 participants were screened. Of them, 201 participants were randomized, and 196 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Sodium : Acetaminophen Participants received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2 | 96 |
| Acetaminophen : Naproxen Sodium Participants received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2 | 100 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inadequate pain reporter | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Other | 3 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Acetaminophen : Naproxen Sodium | Naproxen Sodium : Acetaminophen | Total |
|---|---|---|---|
| Age, Continuous | 25.0 years STANDARD_DEVIATION 5.77 | 24.7 years STANDARD_DEVIATION 5.6 | 24.8 years STANDARD_DEVIATION 5.67 |
| At least moderate pain intensity during 4 of last 6 menstrual cycles No | 0 Participants | 0 Participants | 0 Participants |
| At least moderate pain intensity during 4 of last 6 menstrual cycles Yes | 100 Participants | 96 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 83 Participants | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 23 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 68 Participants | 66 Participants | 134 Participants |
| Sex: Female, Male Female | 100 Participants | 96 Participants | 196 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 192 | 0 / 185 |
| other Total, other adverse events | 12 / 192 | 9 / 185 |
| serious Total, serious adverse events | 0 / 192 | 0 / 185 |
Outcome results
Primary
Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 46. Higher scores was indicative of more pain relief.
Time frame: Up to 12 hours post-dose
Population: PP population per treatment received (included all participants who were randomized and provided at least one measure of an efficacy parameter after the first dose of investigational medicinal product \[IMP\] without any major protocol violations)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | 29.18 Scores on a scale * hours | Standard Error 1.003 |
| Acetaminophen | Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | 24.87 Scores on a scale * hours | Standard Error 1.029 |
p-value: <0.00195% CI: [2.06, 6.56]ANCOVA
Secondary
Number of Participants by Global Evaluation Scores
Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
Time frame: Up to 12 hours post-dose
Population: Subjects who were assessed for this endpoint in PP population per treatment received
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Naproxen Sodium | Number of Participants by Global Evaluation Scores | Fair | 26 Participants |
| Naproxen Sodium | Number of Participants by Global Evaluation Scores | Very good | 60 Participants |
| Naproxen Sodium | Number of Participants by Global Evaluation Scores | Good | 25 Participants |
| Naproxen Sodium | Number of Participants by Global Evaluation Scores | Excellent | 35 Participants |
| Naproxen Sodium | Number of Participants by Global Evaluation Scores | Poor | 10 Participants |
| Acetaminophen | Number of Participants by Global Evaluation Scores | Excellent | 25 Participants |
| Acetaminophen | Number of Participants by Global Evaluation Scores | Poor | 13 Participants |
| Acetaminophen | Number of Participants by Global Evaluation Scores | Fair | 42 Participants |
| Acetaminophen | Number of Participants by Global Evaluation Scores | Good | 38 Participants |
| Acetaminophen | Number of Participants by Global Evaluation Scores | Very good | 38 Participants |
p-value: =0.002Cochran-Mantel-Haenszel
Secondary
Pain Intensity Difference (PID) Scores at Each Evaluation
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement.
Time frame: Up to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 30 minutes | 0.8 Scores on a scale | Standard Deviation 1.47 |
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 1 hour | 1.9 Scores on a scale | Standard Deviation 1.93 |
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 3 hours | 4.1 Scores on a scale | Standard Deviation 2.4 |
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 6 hours | 5.1 Scores on a scale | Standard Deviation 2.59 |
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 9 hours | 4.9 Scores on a scale | Standard Deviation 2.93 |
| Naproxen Sodium | Pain Intensity Difference (PID) Scores at Each Evaluation | 12 hours | 5.0 Scores on a scale | Standard Deviation 2.97 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 9 hours | 3.6 Scores on a scale | Standard Deviation 3.13 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 30 minutes | 0.9 Scores on a scale | Standard Deviation 1.61 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 6 hours | 4.3 Scores on a scale | Standard Deviation 2.9 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 1 hour | 2.1 Scores on a scale | Standard Deviation 2.01 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 12 hours | 3.5 Scores on a scale | Standard Deviation 3.37 |
| Acetaminophen | Pain Intensity Difference (PID) Scores at Each Evaluation | 3 hours | 4.0 Scores on a scale | Standard Deviation 2.68 |
Secondary
Pain Relief Scores at Each Evaluation
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Time frame: Up to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 30 minutes | 0.9 Scores on a scale | Standard Deviation 0.98 |
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 1 hour | 1.4 Scores on a scale | Standard Deviation 1.06 |
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 3 hours | 2.3 Scores on a scale | Standard Deviation 1.17 |
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 6 hours | 2.7 Scores on a scale | Standard Deviation 1.45 |
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 9 hours | 2.6 Scores on a scale | Standard Deviation 1.52 |
| Naproxen Sodium | Pain Relief Scores at Each Evaluation | 12 hours | 2.7 Scores on a scale | Standard Deviation 1.6 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 9 hours | 2.0 Scores on a scale | Standard Deviation 1.57 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 30 minutes | 0.9 Scores on a scale | Standard Deviation 1.01 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 6 hours | 2.4 Scores on a scale | Standard Deviation 1.5 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 1 hour | 1.6 Scores on a scale | Standard Deviation 1.12 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 12 hours | 1.9 Scores on a scale | Standard Deviation 1.69 |
| Acetaminophen | Pain Relief Scores at Each Evaluation | 3 hours | 2.3 Scores on a scale | Standard Deviation 1.32 |
Secondary
SPID Over 0-6 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55.
Time frame: Up to 6 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | SPID Over 0-6 Hours | 23.47 Scores on a scale * hours | Standard Error 0.902 |
| Acetaminophen | SPID Over 0-6 Hours | 21.94 Scores on a scale * hours | Standard Error 0.925 |
p-value: =0.12995% CI: [-0.45, 3.49]ANCOVA
Secondary
SPID Over 6-12 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60.
Time frame: From 6 hours to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | SPID Over 6-12 Hours | 30.15 Scores on a scale * hours | Standard Error 1.252 |
| Acetaminophen | SPID Over 6-12 Hours | 21.88 Scores on a scale * hours | Standard Error 1.28 |
p-value: <0.00195% CI: [5.76, 10.78]ANCOVA
Secondary
Summed Pain Intensity Difference (SPID) Over 0-12 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115.
Time frame: Up to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | Summed Pain Intensity Difference (SPID) Over 0-12 Hours | 53.62 Scores on a scale * hours | Standard Error 1.931 |
| Acetaminophen | Summed Pain Intensity Difference (SPID) Over 0-12 Hours | 43.82 Scores on a scale * hours | Standard Error 1.977 |
p-value: <0.00195% CI: [5.75, 13.85]ANCOVA
Secondary
Time to First Intake of Rescue Medication
Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment.
Time frame: Up to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Time to First Intake of Rescue Medication | NA Hours |
| Acetaminophen | Time to First Intake of Rescue Medication | NA Hours |
p-value: <0.001Log Rank
Secondary
TOTPAR 6-12 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 24. Higher scores was indicative of more pain relief.
Time frame: From 6 hours to 12 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | TOTPAR 6-12 Hours | 15.72 Scores on a scale * hours | Standard Error 0.661 |
| Acetaminophen | TOTPAR 6-12 Hours | 11.97 Scores on a scale * hours | Standard Error 0.677 |
p-value: <0.00195% CI: [2.34, 5.16]ANCOVA
Secondary
TOTPAR Over 0-6 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = 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 is 0, and the maximum value is 22. Higher scores was indicative of more pain relief.
Time frame: Up to 6 hours post-dose
Population: PP population per treatment received
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Naproxen Sodium | TOTPAR Over 0-6 Hours | 13.46 Scores on a scale * hours | Standard Error 0.451 |
| Acetaminophen | TOTPAR Over 0-6 Hours | 12.90 Scores on a scale * hours | Standard Error 0.463 |
p-value: =0.30795% CI: [-0.52, 1.64]ANCOVA