Pain
Conditions
Keywords
Dental pain analgesia
Brief summary
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
Interventions
DRUGplacebo
2 placebo gels capsules delivered as a single dose.
DRUGibuprofen Formulation 1
2 marketed ibuprofen gels
DRUGibuprofen Formulation 2
2 marketed ibuprofen gels
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
: * Outpatients with post-operative pain following surgical extraction of third molars, * examined by the attending dentist or physician and medically cleared to participate in the study, * in general good health and have no contraindications to the study or rescue medication. Exclusions criteria: * any serious medical condition, * acute localized dental infection at the time of surgery , * females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Meaningful Pain Relief | 0-6 hours | Subjects evaluated the time to First Perceptible Relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to Meaningful Relief by depressing a second stopwatch at the moment they first began to experience meaningful relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief (PR) Scores at Individual Time Points | 0-6 hours | Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken. |
| Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-2 and 0-6 hours | SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best). |
| Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 0-6 hours | PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best). |
| Pain Intensity Difference (PID) Scores at Each Individual Time Points | 0-6 hours | PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement. |
| Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-2 and 0-6 hours | TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best) |
| Time to First Perceptible Relief | 0-6 hours | The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief. |
| Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-2 and 0-6 hours | SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best). |
Countries
United States
Participant flow
Recruitment details
Patients were recruited in the United States from August 2008 to October 2008.
Pre-assignment details
During the screening period, the Investigator or his/her designee examined each subject and completed a checklist of the inclusion/exclusion criteria in order to determine the patient's eligibility. Surgery occurred within 14 days of the screening visit.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 2 placebo gel capsules delivered as a single dose up to 5 hours after surgery | 33 |
| Ibuprofen Formulation 1 2 marketed ibuprofen 200 mg liquid gels up to 5 hours after surgery | 88 |
| Ibuprofen Formulation 2 2 marketed ibuprofen 200 mg soft gels up to 5 hours after surgery | 90 |
| Total | 211 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Ibuprofen Formulation 1 | Ibuprofen Formulation 2 | Total |
|---|---|---|---|---|
| Age Continuous | 18.8 years STANDARD_DEVIATION 2.7 | 18.5 years STANDARD_DEVIATION 2.5 | 19.0 years STANDARD_DEVIATION 3 | 18.8 years STANDARD_DEVIATION 2.7 |
| Sex: Female, Male Female | 16 Participants | 43 Participants | 45 Participants | 104 Participants |
| Sex: Female, Male Male | 17 Participants | 45 Participants | 45 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 33 | 2 / 88 | 7 / 90 |
| serious Total, serious adverse events | 0 / 33 | 0 / 88 | 0 / 90 |
Outcome results
Primary
Time to Meaningful Pain Relief
Subjects evaluated the time to First Perceptible Relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to Meaningful Relief by depressing a second stopwatch at the moment they first began to experience meaningful relief. These times were recorded up to 6 hrs after dosing. Range: up to 6 hrs, a lower number is better.
Time frame: 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ibuprofen Formulation 1 | Time to Meaningful Pain Relief | 45.4 minutes |
| Ibuprofen Formulation 2 | Time to Meaningful Pain Relief | 63.6 minutes |
p-value: <0.001Proportional hazards model
p-value: 0.001Proportional hazards model
p-value: <0.001Proportional hazards model
Secondary
Pain Intensity Difference (PID) Scores at Each Individual Time Points
PID is based on the 4-point categorical pain severity score ranging from 0 (none) to 3 (severe), this value was derived by subtracting the score at each post-dosing time point from the baseline score, so that a higher positive value is indicative of greater improvement.
Time frame: 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 120 minutes | 0.2 units on scale | Standard Deviation 0.8 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 30 minutes | 0.2 units on scale | Standard Deviation 0.5 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 15 minutes | 0.1 units on scale | Standard Deviation 0.4 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 60 minutes | 0.3 units on scale | Standard Deviation 0.7 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 45 minutes | 0.3 units on scale | Standard Deviation 0.7 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 240 minutes | 0.4 units on scale | Standard Deviation 1.2 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 300 minutes | 0.2 units on scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 360 minutes | 0.2 units on scale | Standard Deviation 1 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 90 minutes | 0.2 units on scale | Standard Deviation 0.8 |
| Placebo | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 180 minutes | 0.3 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 90 minutes | 1.8 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 120 minutes | 1.8 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 180 minutes | 1.7 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 240 minutes | 1.5 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 15 minutes | 0.2 units on scale | Standard Deviation 0.5 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 300 minutes | 1.4 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 30 minutes | 0.8 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 45 minutes | 1.3 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 60 minutes | 1.6 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 1 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 360 minutes | 1.2 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 240 minutes | 1.5 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 300 minutes | 1.4 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 360 minutes | 1.3 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 15 minutes | 0.1 units on scale | Standard Deviation 0.3 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 30 minutes | 0.5 units on scale | Standard Deviation 0.6 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 60 minutes | 1.2 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 90 minutes | 1.5 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 120 minutes | 1.7 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 180 minutes | 1.7 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 2 | Pain Intensity Difference (PID) Scores at Each Individual Time Points | 45 minutes | 0.9 units on scale | Standard Deviation 0.7 |
Comparison: 15 minutesp-value: 0.118ANOVA
Comparison: The 30, 45, 60....p-value: <0.001ANOVA
Secondary
Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points
PRID (PRID=PID+PR) is a derived endpoint from the pain relief and pain intensity difference scores at each time point. Range: -1 (worst) to 7 (best).
Time frame: 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 15 minutes | 0.3 units on scale | Standard Deviation 0.8 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 300 minutes | 1.0 units on scale | Standard Deviation 2.1 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 360 minutes | 1.0 units on scale | Standard Deviation 2.2 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 30 minutes | 0.8 units on scale | Standard Deviation 1.2 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 45 minutes | 1.1 units on scale | Standard Deviation 1.6 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 60 minutes | 1.2 units on scale | Standard Deviation 1.8 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 90 minutes | 1.0 units on scale | Standard Deviation 1.9 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 120 minutes | 1.0 units on scale | Standard Deviation 2 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 180 minutes | 1.2 units on scale | Standard Deviation 2.4 |
| Placebo | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 240 minutes | 1.5 units on scale | Standard Deviation 2.7 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 45 minutes | 3.6 units on scale | Standard Deviation 1.8 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 240 minutes | 4.2 units on scale | Standard Deviation 2.1 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 30 minutes | 2.4 units on scale | Standard Deviation 1.8 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 90 minutes | 5.0 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 300 minutes | 3.9 units on scale | Standard Deviation 2.3 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 180 minutes | 4.7 units on scale | Standard Deviation 2 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 60 minutes | 4.5 units on scale | Standard Deviation 1.8 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 360 minutes | 3.4 units on scale | Standard Deviation 2.3 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 120 minutes | 5.0 units on scale | Standard Deviation 1.8 |
| Ibuprofen Formulation 1 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 15 minutes | 0.7 units on scale | Standard Deviation 1.2 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 180 minutes | 4.6 units on scale | Standard Deviation 1.8 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 30 minutes | 1.4 units on scale | Standard Deviation 1.5 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 45 minutes | 2.5 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 120 minutes | 4.6 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 60 minutes | 3.3 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 15 minutes | 0.4 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 240 minutes | 4.2 units on scale | Standard Deviation 2 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 300 minutes | 4.0 units on scale | Standard Deviation 2.2 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 90 minutes | 4.2 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 2 | Pain Relief Combined With Pain Intensity Difference (PRID) Scores at Individual Time Points | 360 minutes | 3.9 units on scale | Standard Deviation 2.1 |
Comparison: 15 minutesp-value: 0.056ANOVA
Comparison: The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.p-value: <0.001ANOVA
Secondary
Pain Relief (PR) Scores at Individual Time Points
Response to the question How much pain do you have from your starting pain? was recorded on a 5-point categorical pain relief scale (None (0), A Little (1), Some (2), A Lot (3) or Complete (4)) at designated time points after study medication was taken.
Time frame: 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 15 minutes | 0.2 units on scale | Standard Deviation 0.5 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 360 minutes | 0.8 units on scale | Standard Deviation 1.3 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 180 minutes | 1.0 units on scale | Standard Deviation 1.4 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 300 minutes | 0.8 units on scale | Standard Deviation 1.2 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 90 minutes | 0.8 units on scale | Standard Deviation 1.1 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 45 minutes | 0.8 units on scale | Standard Deviation 1 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 120 minutes | 0.8 units on scale | Standard Deviation 1.2 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 60 minutes | 0.9 units on scale | Standard Deviation 1.1 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 240 minutes | 1.1 units on scale | Standard Deviation 1.6 |
| Placebo | Pain Relief (PR) Scores at Individual Time Points | 30 minutes | 0.6 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 120 minutes | 3.2 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 240 minutes | 2.7 units on scale | Standard Deviation 1.2 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 300 minutes | 2.5 units on scale | Standard Deviation 1.4 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 360 minutes | 2.2 units on scale | Standard Deviation 1.3 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 60 minutes | 2.9 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 15 minutes | 0.5 units on scale | Standard Deviation 0.8 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 30 minutes | 1.6 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 45 minutes | 2.4 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 90 minutes | 3.2 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 1 | Pain Relief (PR) Scores at Individual Time Points | 180 minutes | 3.0 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 30 minutes | 1.0 units on scale | Standard Deviation 0.9 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 240 minutes | 2.7 units on scale | Standard Deviation 1.2 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 90 minutes | 2.7 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 120 minutes | 2.9 units on scale | Standard Deviation 1 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 15 minutes | 0.3 units on scale | Standard Deviation 0.6 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 360 minutes | 2.6 units on scale | Standard Deviation 1.3 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 180 minutes | 2.9 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 300 minutes | 2.6 units on scale | Standard Deviation 1.3 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 45 minutes | 1.7 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 2 | Pain Relief (PR) Scores at Individual Time Points | 60 minutes | 2.1 units on scale | Standard Deviation 1.1 |
Comparison: 15 minutesp-value: 0.041ANOVA
Comparison: The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.p-value: <0.001ANOVA
Secondary
Time to First Perceptible Relief
The elapsed time from dosing until the patient indicated first perceptible relief, provided the subject also indicated achieving meaningful relief.
Time frame: 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS). Median pain relief was not reached for the placebo participants within 360 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ibuprofen Formulation 1 | Time to First Perceptible Relief | 23.7 minutes |
| Ibuprofen Formulation 2 | Time to First Perceptible Relief | 28.6 minutes |
p-value: <0.001proportional hazards model
Secondary
Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours
SPID is a derived endpoint from the pain intensity difference scores from 0-2 hours and 0-6 hours. Range: -2 (worst) to 6 (best); -6 (worst) to 18 (best).
Time frame: 0-2 and 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 0.4 units on scale | Standard Deviation 1.2 |
| Placebo | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 1.4 units on scale | Standard Deviation 5.2 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 2.8 units on scale | Standard Deviation 1.4 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 8.6 units on scale | Standard Deviation 4.8 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 2.2 units on scale | Standard Deviation 1.1 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Intensity Difference (SPID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 8.1 units on scale | Standard Deviation 4.2 |
p-value: <0.001ANOVA
Secondary
Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours
SPRID is a derived endpoint from the pain relief and pain intensity difference scores from 0-2 hours and 0-6 hours. PRID=PID+Pain Relief Score. SPRID-02 range: -2 (worst) to 14 (best); SPRID 06 range: -6 (worst) to 42 (best).
Time frame: 0-2 and 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 6.5 units on scale | Standard Deviation 11.9 |
| Placebo | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 1.8 units on scale | Standard Deviation 2.9 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 24.0 units on scale | Standard Deviation 10.1 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 7.8 units on scale | Standard Deviation 2.9 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-6 hours | 23.0 units on scale | Standard Deviation 9.5 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Relief + Pain Intensity Difference (SPRID) From 0-2 Hours and 0-6 Hours | 0-2 hours | 6.3 units on scale | Standard Deviation 2.6 |
p-value: <0.001ANOVA
Secondary
Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours
TOTPAR is a derived endpoint from the pain relief scores from 0-2 hours and 0-6 hours. Range: 0 (worst) - 8 (best); 0 (worst) - 24 (best)
Time frame: 0-2 and 0-6 hours
Population: All randomized patients who were dosed with study product, indicated a baseline score of at least 2 out of 4 on the Categorical Pain Severity Rating Scale and confirmed a pain assessment of at least 50 mm out of 100 mm on the Visual Analog Scale (VAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-2 hours | 1.4 units on scale | Standard Deviation 1.8 |
| Placebo | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-6 hours | 5.1 units on scale | Standard Deviation 7.1 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-2 hours | 5.0 units on scale | Standard Deviation 1.7 |
| Ibuprofen Formulation 1 | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-6 hours | 15.4 units on scale | Standard Deviation 5.7 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-2 hours | 4.1 units on scale | Standard Deviation 1.6 |
| Ibuprofen Formulation 2 | Time-weighted Sum of Pain Relief Scores (TOTPAR) From 0-2 Hours and 0-6 Hours | 0-6 hours | 14.9 units on scale | Standard Deviation 5.8 |
p-value: <0.001ANOVA