Fever
Conditions
Keywords
ibuprofen; acetaminophen; induced fever; fever
Brief summary
This is a single dose study that will evaluate the efficacy and safety of a Fixed Dose Combination Ibuprofen 250 mg/ Acetaminophen 500 mg tablet in healthy male patients with fever. Results for the Fixed Dose Combination product will be compared to the individual components Ibuprofen 250 mg and Acetaminophen 500 mg and also compared to placebo.
Interventions
Ibuprofen 250 mg / Acetaminophen 500 mg
DRUGIbuprofen 250 mg
Ibuprofen 250 mg
1 APAP 500 mg caplet
DRUGPlacebo
Placebo tablet
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. 2. The subject must have a normal, stable body temperature at Screening and on Day 0. If the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional oral temperature readings will be obtained within a 30 minute period. These 3 consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest value within 0.4°F of the lowest temperature value. 3. Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening. 4. The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.
Exclusion criteria
1. Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within the last 5 years that may increase the risk associated with study participation. 2. Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy, esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected obstructive disease, previous gastrointestinal surgery, felinization of the esophagus, hypomotility of the gastrointestinal track) that could affect the absorption, metabolism, or excretion of the study medication or affect the results of the ingestible thermometer. 3. Subjects at risk for excessive bleeding. 4. Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease. 5. Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three consecutive BP values should be used to determine the subject's eligibility. 6. Screening supine 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening and on Day 1 prior to RSE administration. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three consecutive QTc or QRS values should be used to determine the subject's eligibility. 7. The subject has a history of recurrent or acute or chronic infections of any type or any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc., or those with a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C antibody, and/or Human immunodeficiency virus (HIV) test at Screening. Also excluded are subjects with frequent (more than 3 outbreaks per year), recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study. 8. Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks prior to the first administration of study treatments. 9. Subjects with a reduction in heart rate to ≤50 beats per minute or deemed to be at high risk of syncope and/or hypotension per the clinical judgment of the investigator following a carotid sinus massage procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | 0 to 8 hours post-dose | WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose | WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour). |
| Time to Return to Normal Body Temperature | Baseline (pre-dose) up to 8 hours post dose | Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose. |
| Time to Rescue Medication | 0 to 8 hours post dose | Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study. |
| Time Weighted Sum of Temperature Difference From 6 to 8 Hours | 6 to 8 hours postdose | WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Baseline up to 24 hours after discharge (up to 32 hours) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. |
Countries
United States
Participant flow
Pre-assignment details
In this study, participants were administered at least 1 test dose of reference standard endotoxin (RSE) intravenously, based on their body weight before randomization, to induce pyrexia in them.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo as single oral dose tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 29 |
| Ibuprofen 250 mg+Acetaminophen 500 mg Participants received single oral dose of a fixed dose combination of ibuprofen 250 mg and acetaminophen 500 mg tablets during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 87 |
| Ibuprofen 250 mg Participants received single oral dose of ibuprofen 250 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 87 |
| Acetaminophen 500 mg Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment. | 87 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 6 | 5 | 6 |
| Overall Study | Other | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo | Ibuprofen 250 mg+Acetaminophen 500 mg | Ibuprofen 250 mg | Acetaminophen 500 mg |
|---|---|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 10.07 | 28.8 years STANDARD_DEVIATION 7.97 | 33.4 years STANDARD_DEVIATION 10.54 | 32.3 years STANDARD_DEVIATION 10.19 | 32.6 years STANDARD_DEVIATION 9.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 2 Participants | 4 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 277 Participants | 27 Participants | 83 Participants | 83 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 5 Participants | 10 Participants | 20 Participants | 12 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 1 Participants | 4 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 227 Participants | 21 Participants | 72 Participants | 65 Participants | 69 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 290 Participants | 29 Participants | 87 Participants | 87 Participants | 87 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 / 29 | 0 / 87 | 0 / 87 | 0 / 87 |
| other Total, other adverse events | 1 / 29 | 1 / 87 | 0 / 87 | 0 / 87 |
| serious Total, serious adverse events | 0 / 29 | 0 / 87 | 0 / 87 | 0 / 87 |
Outcome results
Primary
Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours
WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours).
Time frame: 0 to 8 hours post-dose
Population: Modified intent to treat (mITT) population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | 9.28 degrees fahrenheit | Standard Deviation 6.395 |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | 12.54 degrees fahrenheit | Standard Deviation 5.519 |
| Ibuprofen 250 mg | Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | 11.09 degrees fahrenheit | Standard Deviation 6.355 |
| Acetaminophen 500 mg | Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours | 12.39 degrees fahrenheit | Standard Deviation 6.278 |
Comparison: Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.p-value: 0.00295% CI: [1.13, 5.15]ANCOVA
Comparison: Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.p-value: 0.2195% CI: [-0.52, 2.33]ANCOVA
Comparison: Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.p-value: 0.2895% CI: [-0.64, 2.21]ANCOVA
p-value: 0.0395% CI: [0.22, 4.25]ANCOVA
p-value: 0.02395% CI: [0.33, 4.37]ANCOVA
Comparison: Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.p-value: 0.86495% CI: [-1.54, 1.29]ANCOVA
Secondary
Time to Rescue Medication
Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study.
Time frame: 0 to 8 hours post dose
Population: mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Rescue Medication | NA minutes |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time to Rescue Medication | NA minutes |
| Ibuprofen 250 mg | Time to Rescue Medication | NA minutes |
| Acetaminophen 500 mg | Time to Rescue Medication | NA minutes |
p-value: 0.997hazard ratio
p-value: 0.998Hazard Ratio
p-value: 0.997Hazard Ratio
Secondary
Time to Return to Normal Body Temperature
Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose.
Time frame: Baseline (pre-dose) up to 8 hours post dose
Population: mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Return to Normal Body Temperature | 360 minutes |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time to Return to Normal Body Temperature | 330 minutes |
| Ibuprofen 250 mg | Time to Return to Normal Body Temperature | 390 minutes |
| Acetaminophen 500 mg | Time to Return to Normal Body Temperature | 330 minutes |
p-value: 0.449Log Rank
p-value: 0.142Log Rank
p-value: 0.822Log Rank
p-value: 0.671Log Rank
p-value: 0.514Log Rank
p-value: 0.191Log Rank
Secondary
Time Weighted Sum of Temperature Difference From 6 to 8 Hours
WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours).
Time frame: 6 to 8 hours postdose
Population: mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Time Weighted Sum of Temperature Difference From 6 to 8 Hours | 4.96 degrees fahrenheit | Standard Deviation 2.228 |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time Weighted Sum of Temperature Difference From 6 to 8 Hours | 5.69 degrees fahrenheit | Standard Deviation 1.904 |
| Ibuprofen 250 mg | Time Weighted Sum of Temperature Difference From 6 to 8 Hours | 5.49 degrees fahrenheit | Standard Deviation 2.261 |
| Acetaminophen 500 mg | Time Weighted Sum of Temperature Difference From 6 to 8 Hours | 5.84 degrees fahrenheit | Standard Deviation 2.328 |
p-value: 0.10195% CI: [-0.13, 1.48]ANCOVA
p-value: 0.58295% CI: [-0.41, 0.73]ANCOVA
Comparison: Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.p-value: 0.61495% CI: [-0.43, 0.72]ANCOVA
p-value: 0.21295% CI: [-0.29, 1.32]ANCOVA
p-value: 0.20295% CI: [-0.28, 1.34]ANCOVA
p-value: 0.96595% CI: [-0.58, 0.55]ANCOVA
Secondary
Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6
WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour).
Time frame: 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose
Population: mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2 | -0.42 degrees fahrenheit | Standard Deviation 1.827 |
| Placebo | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-6 | 5.26 degrees fahrenheit | Standard Deviation 4.833 |
| Placebo | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-4 | 1.79 degrees fahrenheit | Standard Deviation 3.443 |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2 | 0.48 degrees fahrenheit | Standard Deviation 1.829 |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-6 | 7.95 degrees fahrenheit | Standard Deviation 4.245 |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-4 | 3.69 degrees fahrenheit | Standard Deviation 3.152 |
| Ibuprofen 250 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-4 | 2.61 degrees fahrenheit | Standard Deviation 3.345 |
| Ibuprofen 250 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-6 | 6.65 degrees fahrenheit | Standard Deviation 4.788 |
| Ibuprofen 250 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2 | -0.19 degrees fahrenheit | Standard Deviation 1.856 |
| Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-6 | 7.65 degrees fahrenheit | Standard Deviation 4.604 |
| Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-4 | 3.41 degrees fahrenheit | Standard Deviation 3.173 |
| Acetaminophen 500 mg | Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6 | WSTD 0-2 | 0.21 degrees fahrenheit | Standard Deviation 1.732 |
Comparison: WSTD 0-2 hoursp-value: 0.00495% CI: [0.29, 1.51]ANCOVA
Comparison: WSTD 0-2 hoursp-value: 0.07895% CI: [-0.04, 0.82]ANCOVA
Comparison: WSTD 0-2 hoursp-value: 0.17295% CI: [-0.13, 0.74]ANCOVA
Comparison: WSTD 0-2 hoursp-value: 0.09895% CI: [-0.1, 1.13]ANCOVA
Comparison: WSTD 0-2 hoursp-value: 0.05495% CI: [-0.01, 1.21]ANCOVA
Comparison: WSTD 0-2 hoursp-value: 0.69295% CI: [-0.52, 0.34]ANCOVA
Comparison: WSTD 0-4 hoursp-value: <0.00195% CI: [0.86, 2.88]ANCOVA
Comparison: WSTD 0-4 hoursp-value: 0.09495% CI: [-0.1, 1.33]ANCOVA
Comparison: WSTD 0-4 hoursp-value: 0.21795% CI: [-0.27, 1.17]ANCOVA
Comparison: WSTD 0-4 hoursp-value: 0.01595% CI: [0.24, 2.27]ANCOVA
Comparison: WSTD 0-4 hoursp-value: 0.00695% CI: [0.4, 2.44]ANCOVA
Comparison: WSTD 0-4 hoursp-value: 0.65995% CI: [-0.87, 0.55]ANCOVA
Comparison: WSTD 0-6 hoursp-value: <0.00195% CI: [1.16, 4.08]ANCOVA
Comparison: WSTD 0-6 hoursp-value: 0.13595% CI: [-0.25, 1.82]ANCOVA
Comparison: WSTD 0-6 hoursp-value: 0.18695% CI: [-0.34, 1.74]ANCOVA
Comparison: WSTD 0-6 hoursp-value: 0.01495% CI: [0.37, 3.29]ANCOVA
Comparison: WSTD 0-6 hoursp-value: 0.01195% CI: [0.45, 3.39]ANCOVA
Comparison: WSTD 0-6 hoursp-value: 0.86595% CI: [-1.12, 0.94]ANCOVA
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Time frame: Baseline up to 24 hours after discharge (up to 32 hours)
Population: Safety analysis set included all participants who received study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) | 1 Participants |
| Ibuprofen 250 mg+Acetaminophen 500 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) | 1 Participants |
| Ibuprofen 250 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) | 0 Participants |
| Acetaminophen 500 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) | 0 Participants |