Post-operative Pain
Conditions
Keywords
Dental pain, Ibuprofen, Acetaminophen, Nurofen Plus®, Panadeine® Extra, Paracetamol
Brief summary
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
Detailed description
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators. The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics. The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.
Interventions
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
DRUGIbuprofen/acetaminophen (higher dose)
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
DRUGNurofen Plus®
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
DRUGPanadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
DRUGPlacebo
Two placebo tablets, single dose taken orally with 300 ml water
Sponsors
Premier Research
Aptuit
Reckitt Benckiser LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: Experiencing moderate to severe pain after extraction of impacted third molars Main
Exclusion criteria
Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose | SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4, 0-6, 0-8 and 0-12 hours | Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' |
| Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4, 0-6, 0-8 and 0-12 hours | Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?' Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete. |
| Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours | SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?' |
| Individual Pain Intensity Differences (Ordinal) | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours | Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?' PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain. |
| Change From Baseline in AUC (0-8h) of SPRID | 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose | SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?' |
| Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose | Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?' PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain. |
| Change From Baseline in Peak Pain Relief (PR) | 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose | Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?' Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete. |
| Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | At 12 hours | Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?' Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent. |
| Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours | Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.' |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited in three centres, Salt Lake City (243 subjects randomised), San Marcos (229 subjects randomised) and Austin (206 subjects randomised)
Pre-assignment details
A total of 678 subjects were randomised into the study.173 subjects received ibuprofen 200 mg + paracetamol 500 mg, 169 subjects received Nurofen Plus®, 168 subjects received ibuprofen 400 mg + paracetamol 1000 mg, 113 subjects received Panadeine® Extra and 55 subjects received placebo.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth | 173 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth | 168 |
| Nurofen Plus® Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth | 169 |
| Panadeine® Extra Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth | 113 |
| Placebo Two placebo tablets by mouth | 55 |
| Total | 678 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Nurofen Plus® | Panadeine® Extra | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 20.2 years STANDARD_DEVIATION 3.3 | 19.8 years STANDARD_DEVIATION 3.2 | 20.1 years STANDARD_DEVIATION 3.4 | 19.7 years STANDARD_DEVIATION 3.3 | 19.8 years STANDARD_DEVIATION 3.6 | 20.0 years STANDARD_DEVIATION 3.3 |
| Current smoker | 16 participants | 16 participants | 16 participants | 14 participants | 5 participants | 67 participants |
| Drink alcohol | 63 participants | 61 participants | 61 participants | 36 participants | 15 participants | 236 participants |
| Former smoker | 27 participants | 23 participants | 20 participants | 13 participants | 9 participants | 92 participants |
| Height | 168.5 cm STANDARD_DEVIATION 10 | 169.3 cm STANDARD_DEVIATION 10.1 | 169.5 cm STANDARD_DEVIATION 9.8 | 168.5 cm STANDARD_DEVIATION 9.7 | 168.7 cm STANDARD_DEVIATION 9.5 | 168.9 cm STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants | 1 Participants | 2 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 2 Participants | 3 Participants | 2 Participants | 15 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 | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 165 Participants | 158 Participants | 154 Participants | 107 Participants | 51 Participants | 635 Participants |
| Region of Enrollment United States | 173 participants | 168 participants | 169 participants | 113 participants | 55 participants | 678 participants |
| Sex: Female, Male Female | 105 Participants | 100 Participants | 101 Participants | 68 Participants | 33 Participants | 407 Participants |
| Sex: Female, Male Male | 68 Participants | 68 Participants | 68 Participants | 45 Participants | 22 Participants | 271 Participants |
| Used drugs of abuse | 32 participants | 31 participants | 37 participants | 18 participants | 8 participants | 126 participants |
| Weight | 68.1 kg STANDARD_DEVIATION 14.5 | 69.0 kg STANDARD_DEVIATION 15.2 | 68.8 kg STANDARD_DEVIATION 15.3 | 70.8 kg STANDARD_DEVIATION 16.1 | 71.0 kg STANDARD_DEVIATION 18.7 | 69.2 kg STANDARD_DEVIATION 15.5 |
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 / 173 | 0 / 168 | 0 / 169 | 0 / 113 | 0 / 55 |
| other Total, other adverse events | 88 / 173 | 87 / 168 | 97 / 169 | 72 / 113 | 35 / 55 |
| serious Total, serious adverse events | 0 / 173 | 0 / 168 | 0 / 169 | 0 / 113 | 0 / 55 |
Outcome results
Primary
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Population: Intention-to-treat (ITT) population includes all randomized subjects who took the study medication, completed the baseline efficacy assessments and had at least one post-baseline assessment. Any subjects with treatment administration errors were analyzed according to the treatment to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 2.68 units on a scale*hour | Standard Deviation 1.59 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 3.30 units on a scale*hour | Standard Deviation 1.67 |
| Nurofen Plus® | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 2.62 units on a scale*hour | Standard Deviation 1.73 |
| Panadeine® Extra | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 1.93 units on a scale*hour | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | 0.54 units on a scale*hour | Standard Deviation 1.37 |
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
p-value: 0.0001ANOVA
p-value: 0.0001ANOVA
p-value: 0.72ANOVA
p-value: <0.0001ANOVA
p-value: 0.0005ANOVA
p-value: 0.0005ANOVA
p-value: <0.0001ANOVA
p-value: <0.0001ANOVA
Secondary
Change From Baseline in AUC (0-8h) of SPRID
SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-4h | 3.65 units on a scale*hour | Standard Deviation 1.6 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-8h | 3.39 units on a scale*hour | Standard Deviation 1.71 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-6h | 3.66 units on a scale*hour | Standard Deviation 1.68 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-6h | 4.06 units on a scale*hour | Standard Deviation 1.64 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-4h | 3.95 units on a scale*hour | Standard Deviation 1.52 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC (0-8h) of SPRID | 0-8h | 3.91 units on a scale*hour | Standard Deviation 1.69 |
| Nurofen Plus® | Change From Baseline in AUC (0-8h) of SPRID | 0-6h | 3.45 units on a scale*hour | Standard Deviation 1.82 |
| Nurofen Plus® | Change From Baseline in AUC (0-8h) of SPRID | 0-4h | 3.44 units on a scale*hour | Standard Deviation 1.72 |
| Nurofen Plus® | Change From Baseline in AUC (0-8h) of SPRID | 0-8h | 3.22 units on a scale*hour | Standard Deviation 1.85 |
| Panadeine® Extra | Change From Baseline in AUC (0-8h) of SPRID | 0-4h | 3.19 units on a scale*hour | Standard Deviation 1.61 |
| Panadeine® Extra | Change From Baseline in AUC (0-8h) of SPRID | 0-8h | 2.48 units on a scale*hour | Standard Deviation 1.57 |
| Panadeine® Extra | Change From Baseline in AUC (0-8h) of SPRID | 0-6h | 2.86 units on a scale*hour | Standard Deviation 1.62 |
| Placebo | Change From Baseline in AUC (0-8h) of SPRID | 0-6h | 0.60 units on a scale*hour | Standard Deviation 1.32 |
| Placebo | Change From Baseline in AUC (0-8h) of SPRID | 0-4h | 0.61 units on a scale*hour | Standard Deviation 1.26 |
| Placebo | Change From Baseline in AUC (0-8h) of SPRID | 0-8h | 0.57 units on a scale*hour | Standard Deviation 1.31 |
Secondary
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Time frame: 0-4, 0-6, 0-8 and 0-12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4h | 1.32 units on a scale*hour | Standard Deviation 0.73 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-6h | 1.32 units on a scale*hour | Standard Deviation 0.74 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-8h | 1.21 units on a scale*hour | Standard Deviation 0.73 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-12h | 0.94 units on a scale*hour | Standard Deviation 0.64 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4h | 1.46 units on a scale*hour | Standard Deviation 0.72 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-12h | 1.18 units on a scale*hour | Standard Deviation 0.69 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-6h | 1.50 units on a scale*hour | Standard Deviation 0.75 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-8h | 1.43 units on a scale*hour | Standard Deviation 0.75 |
| Nurofen Plus® | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-12h | 0.91 units on a scale*hour | Standard Deviation 0.67 |
| Nurofen Plus® | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-6h | 1.23 units on a scale*hour | Standard Deviation 0.76 |
| Nurofen Plus® | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-8h | 1.14 units on a scale*hour | Standard Deviation 0.75 |
| Nurofen Plus® | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4h | 1.23 units on a scale*hour | Standard Deviation 0.75 |
| Panadeine® Extra | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4h | 1.13 units on a scale*hour | Standard Deviation 0.7 |
| Panadeine® Extra | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-6h | 1.01 units on a scale*hour | Standard Deviation 0.67 |
| Panadeine® Extra | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-12h | 0.67 units on a scale*hour | Standard Deviation 0.57 |
| Panadeine® Extra | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-8h | 0.87 units on a scale*hour | Standard Deviation 0.63 |
| Placebo | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-12h | 0.19 units on a scale*hour | Standard Deviation 0.56 |
| Placebo | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-8h | 0.19 units on a scale*hour | Standard Deviation 0.53 |
| Placebo | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-6h | 0.19 units on a scale*hour | Standard Deviation 0.53 |
| Placebo | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4h | 0.18 units on a scale*hour | Standard Deviation 0.53 |
Secondary
Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 90 minutes | 4.12 units on a scale | Standard Deviation 1.82 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 30 minutes | 2.49 units on a scale | Standard Deviation 1.63 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 45 minutes | 3.20 units on a scale | Standard Deviation 1.72 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 60 minutes | 3.71 units on a scale | Standard Deviation 1.83 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15 minutes | 1.12 units on a scale | Standard Deviation 1.21 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 2 hours | 4.28 units on a scale | Standard Deviation 1.95 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 3 hours | 4.18 units on a scale | Standard Deviation 2.06 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 4 hours | 4.08 units on a scale | Standard Deviation 2.09 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 5 hours | 3.77 units on a scale | Standard Deviation 2.21 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 6 hours | 3.06 units on a scale | Standard Deviation 2.34 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 7 hours | 2.56 units on a scale | Standard Deviation 2.37 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 8 hours | 2.09 units on a scale | Standard Deviation 2.31 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 9 hours | 1.57 units on a scale | Standard Deviation 2.2 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 10 hours | 1.21 units on a scale | Standard Deviation 2.02 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 11 hours | 0.90 units on a scale | Standard Deviation 1.83 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 12 hours | 0.69 units on a scale | Standard Deviation 1.64 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 10 hours | 2.04 units on a scale | Standard Deviation 2.34 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 6 hours | 3.98 units on a scale | Standard Deviation 2.24 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 5 hours | 4.36 units on a scale | Standard Deviation 2.12 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 11 hours | 1.63 units on a scale | Standard Deviation 2.24 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 4 hours | 4.46 units on a scale | Standard Deviation 2.09 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 90 minutes | 4.44 units on a scale | Standard Deviation 1.69 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 60 minutes | 4.04 units on a scale | Standard Deviation 1.66 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 30 minutes | 2.79 units on a scale | Standard Deviation 1.62 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15 minutes | 1.29 units on a scale | Standard Deviation 1.38 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 9 hours | 2.53 units on a scale | Standard Deviation 2.47 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 2 hours | 4.51 units on a scale | Standard Deviation 1.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 45 minutes | 3.52 units on a scale | Standard Deviation 1.64 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 12 hours | 1.34 units on a scale | Standard Deviation 2.14 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 8 hours | 2.79 units on a scale | Standard Deviation 2.49 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 7 hours | 3.51 units on a scale | Standard Deviation 2.4 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 3 hours | 4.53 units on a scale | Standard Deviation 1.95 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 10 hours | 1.30 units on a scale | Standard Deviation 2.06 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 60 minutes | 3.49 units on a scale | Standard Deviation 1.98 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 90 minutes | 3.92 units on a scale | Standard Deviation 2.06 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 2 hours | 4.17 units on a scale | Standard Deviation 2.14 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 3 hours | 4.02 units on a scale | Standard Deviation 2.14 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 4 hours | 3.78 units on a scale | Standard Deviation 2.31 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 11 hours | 1.12 units on a scale | Standard Deviation 2.02 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 5 hours | 3.52 units on a scale | Standard Deviation 2.4 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 6 hours | 2.98 units on a scale | Standard Deviation 2.47 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 7 hours | 2.54 units on a scale | Standard Deviation 2.5 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 8 hours | 2.08 units on a scale | Standard Deviation 2.38 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 9 hours | 1.68 units on a scale | Standard Deviation 2.2 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15 minutes | 0.78 units on a scale | Standard Deviation 1.22 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 12 hours | 0.96 units on a scale | Standard Deviation 1.85 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 30 minutes | 2.08 units on a scale | Standard Deviation 1.71 |
| Nurofen Plus® | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 45 minutes | 2.92 units on a scale | Standard Deviation 1.84 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 6 hours | 1.70 units on a scale | Standard Deviation 2.16 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 12 hours | 0.74 units on a scale | Standard Deviation 1.76 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 7 hours | 1.31 units on a scale | Standard Deviation 2 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 10 hours | 0.81 units on a scale | Standard Deviation 1.84 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 8 hours | 1.02 units on a scale | Standard Deviation 1.92 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 2 hours | 3.91 units on a scale | Standard Deviation 1.9 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 9 hours | 0.91 units on a scale | Standard Deviation 1.87 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 60 minutes | 3.81 units on a scale | Standard Deviation 1.83 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15 minutes | 1.01 units on a scale | Standard Deviation 1.4 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 45 minutes | 3.39 units on a scale | Standard Deviation 1.8 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 4 hours | 2.79 units on a scale | Standard Deviation 2.21 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 90 minutes | 3.96 units on a scale | Standard Deviation 1.77 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 5 hours | 2.23 units on a scale | Standard Deviation 2.2 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 11 hours | 0.76 units on a scale | Standard Deviation 1.77 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 3 hours | 3.31 units on a scale | Standard Deviation 2.13 |
| Panadeine® Extra | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 30 minutes | 2.62 units on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 9 hours | 0.47 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 6 hours | 0.53 units on a scale | Standard Deviation 1.56 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 11 hours | 0.49 units on a scale | Standard Deviation 1.62 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 90 minutes | 0.60 units on a scale | Standard Deviation 1.56 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 30 minutes | 0.58 units on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 4 hours | 0.64 units on a scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 7 hours | 0.45 units on a scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 12 hours | 0.49 units on a scale | Standard Deviation 1.62 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 2 hours | 0.67 units on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 5 hours | 0.60 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 15 minutes | 0.29 units on a scale | Standard Deviation 0.74 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 8 hours | 0.40 units on a scale | Standard Deviation 1.3 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 3 hours | 1.66 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 10 hours | 0.49 units on a scale | Standard Deviation 1.62 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 60 minutes | 0.71 units on a scale | Standard Deviation 1.49 |
| Placebo | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) | 45 minutes | 0.65 units on a scale | Standard Deviation 1.38 |
Secondary
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?' Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Time frame: 0-4, 0-6, 0-8 and 0-12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4h | 2.33 units on a scale*hour | Standard Deviation 0.96 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-6h | 2.34 units on a scale*hour | Standard Deviation 1.02 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-8h | 2.18 units on a scale*hour | Standard Deviation 1.05 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-12h | 1.73 units on a scale*hour | Standard Deviation 1.01 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4h | 2.48 units on a scale*hour | Standard Deviation 0.9 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-12h | 2.12 units on a scale*hour | Standard Deviation 1.06 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-6h | 2.56 units on a scale*hour | Standard Deviation 0.98 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-8h | 2.48 units on a scale*hour | Standard Deviation 1.03 |
| Nurofen Plus® | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-12h | 1.70 units on a scale*hour | Standard Deviation 1.11 |
| Nurofen Plus® | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-6h | 2.22 units on a scale*hour | Standard Deviation 1.12 |
| Nurofen Plus® | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-8h | 2.08 units on a scale*hour | Standard Deviation 1.15 |
| Nurofen Plus® | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4h | 2.20 units on a scale*hour | Standard Deviation 1.04 |
| Panadeine® Extra | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4h | 2.05 units on a scale*hour | Standard Deviation 1 |
| Panadeine® Extra | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-6h | 1.85 units on a scale*hour | Standard Deviation 1.03 |
| Panadeine® Extra | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-12h | 1.27 units on a scale*hour | Standard Deviation 0.98 |
| Panadeine® Extra | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-8h | 1.61 units on a scale*hour | Standard Deviation 1.01 |
| Placebo | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-12h | 0.34 units on a scale*hour | Standard Deviation 0.82 |
| Placebo | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-8h | 0.38 units on a scale*hour | Standard Deviation 0.81 |
| Placebo | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-6h | 0.41 units on a scale*hour | Standard Deviation 0.82 |
| Placebo | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4h | 0.42 units on a scale*hour | Standard Deviation 0.77 |
Secondary
Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?' PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 1.78 units on a scale | Standard Deviation 0.83 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 1.93 units on a scale | Standard Deviation 0.81 |
| Nurofen Plus® | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 1.74 units on a scale | Standard Deviation 0.87 |
| Panadeine® Extra | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 1.63 units on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) | 0.60 units on a scale | Standard Deviation 0.87 |
Secondary
Change From Baseline in Peak Pain Relief (PR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?' Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Time frame: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Change From Baseline in Peak Pain Relief (PR) | 3.06 units on a scale | Standard Deviation 1 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Change From Baseline in Peak Pain Relief (PR) | 3.25 units on a scale | Standard Deviation 0.89 |
| Nurofen Plus® | Change From Baseline in Peak Pain Relief (PR) | 2.98 units on a scale | Standard Deviation 1.11 |
| Panadeine® Extra | Change From Baseline in Peak Pain Relief (PR) | 2.88 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in Peak Pain Relief (PR) | 0.96 units on a scale | Standard Deviation 1.15 |
Secondary
Individual Pain Intensity Differences (Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?' PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 3 hours | 1.54 units on a scale | Standard Deviation 0.91 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 4 hours | 1.49 units on a scale | Standard Deviation 0.91 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 10 hours | 0.40 units on a scale | Standard Deviation 0.74 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 5 hours | 1.35 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 12 hours | 0.21 units on a scale | Standard Deviation 0.57 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 6 hours | 1.07 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 60 minutes | 1.31 units on a scale | Standard Deviation 0.85 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 9 hours | 0.53 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 8 hours | 0.71 units on a scale | Standard Deviation 0.89 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 45 minutes | 1.14 units on a scale | Standard Deviation 0.76 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 90 minutes | 1.49 units on a scale | Standard Deviation 0.83 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 11 hours | 0.27 units on a scale | Standard Deviation 0.64 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 15 minutes | 0.40 units on a scale | Standard Deviation 0.57 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 2 hours | 1.54 units on a scale | Standard Deviation 0.89 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 7 hours | 0.89 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences (Ordinal) | 30 minutes | 0.94 units on a scale | Standard Deviation 0.76 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 90 minutes | 1.61 units on a scale | Standard Deviation 0.84 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 10 hours | 0.67 units on a scale | Standard Deviation 0.87 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 15 minutes | 0.46 units on a scale | Standard Deviation 0.64 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 30 minutes | 1.03 units on a scale | Standard Deviation 0.74 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 60 minutes | 1.48 units on a scale | Standard Deviation 0.79 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 45 minutes | 1.27 units on a scale | Standard Deviation 0.76 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 6 hours | 1.44 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 2 hours | 1.69 units on a scale | Standard Deviation 0.87 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 7 hours | 1.22 units on a scale | Standard Deviation 0.98 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 5 hours | 1.60 units on a scale | Standard Deviation 0.93 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 11 hours | 0.52 units on a scale | Standard Deviation 0.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 3 hours | 1.70 units on a scale | Standard Deviation 0.89 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 12 hours | 0.42 units on a scale | Standard Deviation 0.78 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 9 hours | 0.86 units on a scale | Standard Deviation 0.94 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 8 hours | 0.96 units on a scale | Standard Deviation 0.96 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences (Ordinal) | 4 hours | 1.68 units on a scale | Standard Deviation 0.94 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 6 hours | 1.04 units on a scale | Standard Deviation 0.95 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 10 hours | 0.43 units on a scale | Standard Deviation 0.75 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 11 hours | 0.36 units on a scale | Standard Deviation 0.73 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 15 minutes | 0.23 units on a scale | Standard Deviation 0.58 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 12 hours | 0.30 units on a scale | Standard Deviation 0.63 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 60 minutes | 1.24 units on a scale | Standard Deviation 0.87 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 90 minutes | 1.40 units on a scale | Standard Deviation 0.92 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 2 hours | 1.52 units on a scale | Standard Deviation 0.94 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 3 hours | 1.46 units on a scale | Standard Deviation 0.93 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 4 hours | 1.36 units on a scale | Standard Deviation 0.95 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 30 minutes | 0.73 units on a scale | Standard Deviation 0.8 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 5 hours | 1.24 units on a scale | Standard Deviation 0.96 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 45 minutes | 1.04 units on a scale | Standard Deviation 0.8 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 7 hours | 0.88 units on a scale | Standard Deviation 0.96 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 8 hours | 0.72 units on a scale | Standard Deviation 0.89 |
| Nurofen Plus® | Individual Pain Intensity Differences (Ordinal) | 9 hours | 0.55 units on a scale | Standard Deviation 0.8 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 6 hours | 0.58 units on a scale | Standard Deviation 0.82 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 3 hours | 1.19 units on a scale | Standard Deviation 0.87 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 2 hours | 1.41 units on a scale | Standard Deviation 0.84 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 90 minutes | 1.42 units on a scale | Standard Deviation 0.83 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 10 hours | 0.27 units on a scale | Standard Deviation 0.67 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 7 hours | 0.44 units on a scale | Standard Deviation 0.74 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 15 minutes | 0.31 units on a scale | Standard Deviation 0.64 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 60 minutes | 1.35 units on a scale | Standard Deviation 0.85 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 12 hours | 0.25 units on a scale | Standard Deviation 0.63 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 9 hours | 0.29 units on a scale | Standard Deviation 0.68 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 8 hours | 0.33 units on a scale | Standard Deviation 0.71 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 11 hours | 0.24 units on a scale | Standard Deviation 0.63 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 30 minutes | 0.95 units on a scale | Standard Deviation 0.83 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 5 hours | 0.79 units on a scale | Standard Deviation 0.88 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 4 hours | 0.96 units on a scale | Standard Deviation 0.9 |
| Panadeine® Extra | Individual Pain Intensity Differences (Ordinal) | 45 minutes | 1.19 units on a scale | Standard Deviation 0.83 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 12 hours | 0.20 units on a scale | Standard Deviation 0.68 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 15 minutes | 0.09 units on a scale | Standard Deviation 0.4 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 30 minutes | 0.15 units on a scale | Standard Deviation 0.56 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 45 minutes | 0.16 units on a scale | Standard Deviation 0.63 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 60 minutes | 0.22 units on a scale | Standard Deviation 0.79 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 90 minutes | 0.11 units on a scale | Standard Deviation 0.81 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 2 hours | 0.24 units on a scale | Standard Deviation 0.54 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 3 hours | 0.22 units on a scale | Standard Deviation 0.66 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 4 hours | 0.24 units on a scale | Standard Deviation 0.64 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 5 hours | 0.22 units on a scale | Standard Deviation 0.63 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 6 hours | 0.20 units on a scale | Standard Deviation 0.62 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 7 hours | 0.18 units on a scale | Standard Deviation 0.61 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 8 hours | 0.16 units on a scale | Standard Deviation 0.54 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 9 hours | 0.20 units on a scale | Standard Deviation 0.68 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 10 hours | 0.20 units on a scale | Standard Deviation 0.68 |
| Placebo | Individual Pain Intensity Differences (Ordinal) | 11 hours | 0.20 units on a scale | Standard Deviation 0.68 |
Secondary
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.'
Time frame: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 90 minutes | 48.3 units on a scale | Standard Deviation 25.8 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 30 minutes | 22.8 units on a scale | Standard Deviation 21.4 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 45 minutes | 32.5 units on a scale | Standard Deviation 23.8 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 60 minutes | 40.3 units on a scale | Standard Deviation 25.5 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15 minutes | 9.0 units on a scale | Standard Deviation 13.7 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 2 hours | 50.6 units on a scale | Standard Deviation 26.6 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 3 hours | 51.0 units on a scale | Standard Deviation 27.1 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 4 hours | 50.2 units on a scale | Standard Deviation 27.8 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 5 hours | 45.4 units on a scale | Standard Deviation 28.7 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 6 hours | 36.6 units on a scale | Standard Deviation 30.2 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 7 hours | 30.9 units on a scale | Standard Deviation 30.6 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 8 hours | 25.0 units on a scale | Standard Deviation 28.9 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 9 hours | 17.7 units on a scale | Standard Deviation 26.4 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 10 hours | 14.1 units on a scale | Standard Deviation 25.2 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 11 hours | 9.4 units on a scale | Standard Deviation 21.2 |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 12 hours | 8.0 units on a scale | Standard Deviation 20.4 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 10 hours | 23.7 units on a scale | Standard Deviation 29.1 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 6 hours | 47.9 units on a scale | Standard Deviation 27.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 5 hours | 52.8 units on a scale | Standard Deviation 26.7 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 11 hours | 18.7 units on a scale | Standard Deviation 27.2 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 4 hours | 55.5 units on a scale | Standard Deviation 26.4 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 90 minutes | 52.5 units on a scale | Standard Deviation 24.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 60 minutes | 46.3 units on a scale | Standard Deviation 24.4 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 30 minutes | 26.2 units on a scale | Standard Deviation 21.5 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15 minutes | 10.5 units on a scale | Standard Deviation 16.3 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 9 hours | 29.6 units on a scale | Standard Deviation 30.3 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 2 hours | 54.9 units on a scale | Standard Deviation 25.7 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 45 minutes | 37.5 units on a scale | Standard Deviation 24 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 12 hours | 15.1 units on a scale | Standard Deviation 25.5 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 8 hours | 33.8 units on a scale | Standard Deviation 30.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 7 hours | 41.0 units on a scale | Standard Deviation 29.8 |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 3 hours | 55.9 units on a scale | Standard Deviation 25.5 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 10 hours | 14.9 units on a scale | Standard Deviation 25.3 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 60 minutes | 36.6 units on a scale | Standard Deviation 28.7 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 90 minutes | 43.7 units on a scale | Standard Deviation 28.2 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 2 hours | 47.3 units on a scale | Standard Deviation 29.3 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 3 hours | 48.0 units on a scale | Standard Deviation 29.3 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 4 hours | 45.6 units on a scale | Standard Deviation 29.9 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 11 hours | 12.8 units on a scale | Standard Deviation 24.7 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 5 hours | 42.5 units on a scale | Standard Deviation 30.4 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 6 hours | 35.6 units on a scale | Standard Deviation 30.6 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 7 hours | 29.7 units on a scale | Standard Deviation 30.8 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 8 hours | 24.4 units on a scale | Standard Deviation 29.8 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 9 hours | 18.4 units on a scale | Standard Deviation 27.2 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15 minutes | 4.5 units on a scale | Standard Deviation 14.1 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 12 hours | 11.0 units on a scale | Standard Deviation 22.9 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 30 minutes | 17.7 units on a scale | Standard Deviation 22.5 |
| Nurofen Plus® | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 45 minutes | 28.3 units on a scale | Standard Deviation 25.7 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 6 hours | 18.4 units on a scale | Standard Deviation 27.2 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 12 hours | 9.3 units on a scale | Standard Deviation 22.1 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 7 hours | 15.4 units on a scale | Standard Deviation 25.2 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 10 hours | 9.7 units on a scale | Standard Deviation 22.9 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 8 hours | 11.7 units on a scale | Standard Deviation 24.4 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 2 hours | 45.2 units on a scale | Standard Deviation 27.9 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 9 hours | 10.8 units on a scale | Standard Deviation 22.9 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 60 minutes | 41.5 units on a scale | Standard Deviation 27.1 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15 minutes | 8.7 units on a scale | Standard Deviation 16.6 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 45 minutes | 34.3 units on a scale | Standard Deviation 25.7 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 4 hours | 32.9 units on a scale | Standard Deviation 29.4 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 90 minutes | 44.6 units on a scale | Standard Deviation 25.9 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 5 hours | 25.9 units on a scale | Standard Deviation 29.2 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 11 hours | 9.8 units on a scale | Standard Deviation 23.2 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 3 hours | 38.9 units on a scale | Standard Deviation 29.9 |
| Panadeine® Extra | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 30 minutes | 23.9 units on a scale | Standard Deviation 23.9 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 9 hours | 5.6 units on a scale | Standard Deviation 19.4 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 6 hours | 6.5 units on a scale | Standard Deviation 19.7 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 11 hours | 6.2 units on a scale | Standard Deviation 20.1 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 90 minutes | 0.9 units on a scale | Standard Deviation 22.6 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 30 minutes | 2.2 units on a scale | Standard Deviation 16.7 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 4 hours | 7.2 units on a scale | Standard Deviation 20.3 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 7 hours | 5.8 units on a scale | Standard Deviation 18.8 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 12 hours | 6.4 units on a scale | Standard Deviation 20.8 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 2 hours | 5.0 units on a scale | Standard Deviation 18.2 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 5 hours | 7.2 units on a scale | Standard Deviation 19.8 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 15 minutes | 0.4 units on a scale | Standard Deviation 13.1 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 8 hours | 5.1 units on a scale | Standard Deviation 17.2 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 3 hours | 6.1 units on a scale | Standard Deviation 21.3 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 10 hours | 6.2 units on a scale | Standard Deviation 20.3 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 60 minutes | 1.8 units on a scale | Standard Deviation 19.3 |
| Placebo | Individual Pain Intensity Differences Visual Analogue Scale (VAS) | 45 minutes | 0.9 units on a scale | Standard Deviation 18.8 |
Secondary
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?' Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent.
Time frame: At 12 hours
Population: Three subjects from ITT population were excluded from this analysis due to early/late diary assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 4 Very good | 72 Participants |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 1 Poor | 15 Participants |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 5 Excellent | 23 Participants |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 2 Fair | 16 Participants |
| Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 3 Good | 43 Participants |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 4 Very good | 69 Participants |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 3 Good | 32 Participants |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 2 Fair | 12 Participants |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 5 Excellent | 39 Participants |
| Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 1 Poor | 9 Participants |
| Nurofen Plus® | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 3 Good | 40 Participants |
| Nurofen Plus® | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 1 Poor | 15 Participants |
| Nurofen Plus® | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 2 Fair | 22 Participants |
| Nurofen Plus® | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 4 Very good | 64 Participants |
| Nurofen Plus® | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 5 Excellent | 26 Participants |
| Panadeine® Extra | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 5 Excellent | 7 Participants |
| Panadeine® Extra | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 1 Poor | 12 Participants |
| Panadeine® Extra | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 4 Very good | 34 Participants |
| Panadeine® Extra | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 3 Good | 41 Participants |
| Panadeine® Extra | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 2 Fair | 19 Participants |
| Placebo | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 3 Good | 2 Participants |
| Placebo | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 4 Very good | 3 Participants |
| Placebo | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 1 Poor | 43 Participants |
| Placebo | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 5 Excellent | 1 Participants |
| Placebo | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | 2 Fair | 6 Participants |