Trial Outcomes & Findings for Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study (NCT NCT01229449)
NCT ID: NCT01229449
Last Updated: 2018-09-17
Results Overview
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?'
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
678 participants
Primary outcome timeframe
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
Results posted on
2018-09-17
Participant Flow
Subjects were recruited in three centres, Salt Lake City (243 subjects randomised), San Marcos (229 subjects randomised) and Austin (206 subjects randomised)
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.
Participant milestones
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth (single dose)
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
Two tablets of ibuprofen 200 mg plus two tablets of acetaminophen 500 mg by mouth (single dose)
|
Nurofen Plus®
Two tablets ibuprofen 200 mg plus codeine 12.8 mg (Nurofen Plus®) by mouth (single dose)
|
Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth (single dose)
|
Placebo
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
173
|
168
|
169
|
113
|
55
|
|
Overall Study
COMPLETED
|
172
|
164
|
167
|
112
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth (single dose)
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
Two tablets of ibuprofen 200 mg plus two tablets of acetaminophen 500 mg by mouth (single dose)
|
Nurofen Plus®
Two tablets ibuprofen 200 mg plus codeine 12.8 mg (Nurofen Plus®) by mouth (single dose)
|
Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth (single dose)
|
Placebo
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Baseline characteristics by cohort
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
Total
n=678 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
20.2 years
STANDARD_DEVIATION 3.3 • n=99 Participants
|
19.8 years
STANDARD_DEVIATION 3.2 • n=107 Participants
|
20.1 years
STANDARD_DEVIATION 3.4 • n=206 Participants
|
19.7 years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
19.8 years
STANDARD_DEVIATION 3.6 • n=31 Participants
|
20.0 years
STANDARD_DEVIATION 3.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
407 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
271 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=99 Participants
|
158 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
51 Participants
n=31 Participants
|
635 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
173 participants
n=99 Participants
|
168 participants
n=107 Participants
|
169 participants
n=206 Participants
|
113 participants
n=7 Participants
|
55 participants
n=31 Participants
|
678 participants
n=30 Participants
|
|
Weight
|
68.1 kg
STANDARD_DEVIATION 14.5 • n=99 Participants
|
69.0 kg
STANDARD_DEVIATION 15.2 • n=107 Participants
|
68.8 kg
STANDARD_DEVIATION 15.3 • n=206 Participants
|
70.8 kg
STANDARD_DEVIATION 16.1 • n=7 Participants
|
71.0 kg
STANDARD_DEVIATION 18.7 • n=31 Participants
|
69.2 kg
STANDARD_DEVIATION 15.5 • n=30 Participants
|
|
Height
|
168.5 cm
STANDARD_DEVIATION 10.0 • n=99 Participants
|
169.3 cm
STANDARD_DEVIATION 10.1 • n=107 Participants
|
169.5 cm
STANDARD_DEVIATION 9.8 • n=206 Participants
|
168.5 cm
STANDARD_DEVIATION 9.7 • n=7 Participants
|
168.7 cm
STANDARD_DEVIATION 9.5 • n=31 Participants
|
168.9 cm
STANDARD_DEVIATION 9.9 • n=30 Participants
|
|
Drink alcohol
|
63 participants
n=99 Participants
|
61 participants
n=107 Participants
|
61 participants
n=206 Participants
|
36 participants
n=7 Participants
|
15 participants
n=31 Participants
|
236 participants
n=30 Participants
|
|
Former smoker
|
27 participants
n=99 Participants
|
23 participants
n=107 Participants
|
20 participants
n=206 Participants
|
13 participants
n=7 Participants
|
9 participants
n=31 Participants
|
92 participants
n=30 Participants
|
|
Current smoker
|
16 participants
n=99 Participants
|
16 participants
n=107 Participants
|
16 participants
n=206 Participants
|
14 participants
n=7 Participants
|
5 participants
n=31 Participants
|
67 participants
n=30 Participants
|
|
Used drugs of abuse
|
32 participants
n=99 Participants
|
31 participants
n=107 Participants
|
37 participants
n=206 Participants
|
18 participants
n=7 Participants
|
8 participants
n=31 Participants
|
126 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: 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.
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?'
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
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
|
3.30 units on a scale*hour
Standard Deviation 1.67
|
2.62 units on a scale*hour
Standard Deviation 1.73
|
1.93 units on a scale*hour
Standard Deviation 1.51
|
0.54 units on a scale*hour
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dosePopulation: ITT population
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?'
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in AUC (0-8h) of SPRID
0-4h
|
3.65 units on a scale*hour
Standard Deviation 1.60
|
3.95 units on a scale*hour
Standard Deviation 1.52
|
3.44 units on a scale*hour
Standard Deviation 1.72
|
3.19 units on a scale*hour
Standard Deviation 1.61
|
0.61 units on a scale*hour
Standard Deviation 1.26
|
|
Change From Baseline in AUC (0-8h) of SPRID
0-6h
|
3.66 units on a scale*hour
Standard Deviation 1.68
|
4.06 units on a scale*hour
Standard Deviation 1.64
|
3.45 units on a scale*hour
Standard Deviation 1.82
|
2.86 units on a scale*hour
Standard Deviation 1.62
|
0.60 units on a scale*hour
Standard Deviation 1.32
|
|
Change From Baseline in AUC (0-8h) of SPRID
0-8h
|
3.39 units on a scale*hour
Standard Deviation 1.71
|
3.91 units on a scale*hour
Standard Deviation 1.69
|
3.22 units on a scale*hour
Standard Deviation 1.85
|
2.48 units on a scale*hour
Standard Deviation 1.57
|
0.57 units on a scale*hour
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 0-4, 0-6, 0-8 and 0-12 hoursPopulation: ITT population
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?'
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
0-4h
|
1.32 units on a scale*hour
Standard Deviation 0.73
|
1.46 units on a scale*hour
Standard Deviation 0.72
|
1.23 units on a scale*hour
Standard Deviation 0.75
|
1.13 units on a scale*hour
Standard Deviation 0.70
|
0.18 units on a scale*hour
Standard Deviation 0.53
|
|
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
0-6h
|
1.32 units on a scale*hour
Standard Deviation 0.74
|
1.50 units on a scale*hour
Standard Deviation 0.75
|
1.23 units on a scale*hour
Standard Deviation 0.76
|
1.01 units on a scale*hour
Standard Deviation 0.67
|
0.19 units on a scale*hour
Standard Deviation 0.53
|
|
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
0-8h
|
1.21 units on a scale*hour
Standard Deviation 0.73
|
1.43 units on a scale*hour
Standard Deviation 0.75
|
1.14 units on a scale*hour
Standard Deviation 0.75
|
0.87 units on a scale*hour
Standard Deviation 0.63
|
0.19 units on a scale*hour
Standard Deviation 0.53
|
|
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
0-12h
|
0.94 units on a scale*hour
Standard Deviation 0.64
|
1.18 units on a scale*hour
Standard Deviation 0.69
|
0.91 units on a scale*hour
Standard Deviation 0.67
|
0.67 units on a scale*hour
Standard Deviation 0.57
|
0.19 units on a scale*hour
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 0-4, 0-6, 0-8 and 0-12 hoursPopulation: ITT population
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.
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
0-4h
|
2.33 units on a scale*hour
Standard Deviation 0.96
|
2.48 units on a scale*hour
Standard Deviation 0.90
|
2.20 units on a scale*hour
Standard Deviation 1.04
|
2.05 units on a scale*hour
Standard Deviation 1.00
|
0.42 units on a scale*hour
Standard Deviation 0.77
|
|
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
0-6h
|
2.34 units on a scale*hour
Standard Deviation 1.02
|
2.56 units on a scale*hour
Standard Deviation 0.98
|
2.22 units on a scale*hour
Standard Deviation 1.12
|
1.85 units on a scale*hour
Standard Deviation 1.03
|
0.41 units on a scale*hour
Standard Deviation 0.82
|
|
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
0-8h
|
2.18 units on a scale*hour
Standard Deviation 1.05
|
2.48 units on a scale*hour
Standard Deviation 1.03
|
2.08 units on a scale*hour
Standard Deviation 1.15
|
1.61 units on a scale*hour
Standard Deviation 1.01
|
0.38 units on a scale*hour
Standard Deviation 0.81
|
|
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
0-12h
|
1.73 units on a scale*hour
Standard Deviation 1.01
|
2.12 units on a scale*hour
Standard Deviation 1.06
|
1.70 units on a scale*hour
Standard Deviation 1.11
|
1.27 units on a scale*hour
Standard Deviation 0.98
|
0.34 units on a scale*hour
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hoursPopulation: ITT population
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?'
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
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
|
1.29 units on a scale
Standard Deviation 1.38
|
0.78 units on a scale
Standard Deviation 1.22
|
1.01 units on a scale
Standard Deviation 1.40
|
0.29 units on a scale
Standard Deviation 0.74
|
|
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
|
3.52 units on a scale
Standard Deviation 1.64
|
2.92 units on a scale
Standard Deviation 1.84
|
3.39 units on a scale
Standard Deviation 1.80
|
0.65 units on a scale
Standard Deviation 1.38
|
|
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
|
4.36 units on a scale
Standard Deviation 2.12
|
3.52 units on a scale
Standard Deviation 2.40
|
2.23 units on a scale
Standard Deviation 2.20
|
0.60 units on a scale
Standard Deviation 1.59
|
|
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
|
1.63 units on a scale
Standard Deviation 2.24
|
1.12 units on a scale
Standard Deviation 2.02
|
0.76 units on a scale
Standard Deviation 1.77
|
0.49 units on a scale
Standard Deviation 1.62
|
|
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
|
2.79 units on a scale
Standard Deviation 1.62
|
2.08 units on a scale
Standard Deviation 1.71
|
2.62 units on a scale
Standard Deviation 1.83
|
0.58 units on a scale
Standard Deviation 1.13
|
|
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
|
4.04 units on a scale
Standard Deviation 1.66
|
3.49 units on a scale
Standard Deviation 1.98
|
3.81 units on a scale
Standard Deviation 1.83
|
0.71 units on a scale
Standard Deviation 1.49
|
|
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
|
4.44 units on a scale
Standard Deviation 1.69
|
3.92 units on a scale
Standard Deviation 2.06
|
3.96 units on a scale
Standard Deviation 1.77
|
0.60 units on a scale
Standard Deviation 1.56
|
|
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
|
4.51 units on a scale
Standard Deviation 1.80
|
4.17 units on a scale
Standard Deviation 2.14
|
3.91 units on a scale
Standard Deviation 1.90
|
0.67 units on a scale
Standard Deviation 1.43
|
|
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
|
4.53 units on a scale
Standard Deviation 1.95
|
4.02 units on a scale
Standard Deviation 2.14
|
3.31 units on a scale
Standard Deviation 2.13
|
1.66 units on a scale
Standard Deviation 0.00
|
|
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
|
4.46 units on a scale
Standard Deviation 2.09
|
3.78 units on a scale
Standard Deviation 2.31
|
2.79 units on a scale
Standard Deviation 2.21
|
0.64 units on a scale
Standard Deviation 1.65
|
|
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
|
3.98 units on a scale
Standard Deviation 2.24
|
2.98 units on a scale
Standard Deviation 2.47
|
1.70 units on a scale
Standard Deviation 2.16
|
0.53 units on a scale
Standard Deviation 1.56
|
|
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
|
3.51 units on a scale
Standard Deviation 2.40
|
2.54 units on a scale
Standard Deviation 2.50
|
1.31 units on a scale
Standard Deviation 2.00
|
0.45 units on a scale
Standard Deviation 1.45
|
|
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
|
2.79 units on a scale
Standard Deviation 2.49
|
2.08 units on a scale
Standard Deviation 2.38
|
1.02 units on a scale
Standard Deviation 1.92
|
0.40 units on a scale
Standard Deviation 1.30
|
|
Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
9 hours
|
1.57 units on a scale
Standard Deviation 2.20
|
2.53 units on a scale
Standard Deviation 2.47
|
1.68 units on a scale
Standard Deviation 2.20
|
0.91 units on a scale
Standard Deviation 1.87
|
0.47 units on a scale
Standard Deviation 1.59
|
|
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
|
2.04 units on a scale
Standard Deviation 2.34
|
1.30 units on a scale
Standard Deviation 2.06
|
0.81 units on a scale
Standard Deviation 1.84
|
0.49 units on a scale
Standard Deviation 1.62
|
|
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
|
1.34 units on a scale
Standard Deviation 2.14
|
0.96 units on a scale
Standard Deviation 1.85
|
0.74 units on a scale
Standard Deviation 1.76
|
0.49 units on a scale
Standard Deviation 1.62
|
SECONDARY outcome
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hoursPopulation: ITT population
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.
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Individual Pain Intensity Differences (Ordinal)
12 hours
|
0.21 units on a scale
Standard Deviation 0.57
|
0.42 units on a scale
Standard Deviation 0.78
|
0.30 units on a scale
Standard Deviation 0.63
|
0.25 units on a scale
Standard Deviation 0.63
|
0.20 units on a scale
Standard Deviation 0.68
|
|
Individual Pain Intensity Differences (Ordinal)
2 hours
|
1.54 units on a scale
Standard Deviation 0.89
|
1.69 units on a scale
Standard Deviation 0.87
|
1.52 units on a scale
Standard Deviation 0.94
|
1.41 units on a scale
Standard Deviation 0.84
|
0.24 units on a scale
Standard Deviation 0.54
|
|
Individual Pain Intensity Differences (Ordinal)
15 minutes
|
0.40 units on a scale
Standard Deviation 0.57
|
0.46 units on a scale
Standard Deviation 0.64
|
0.23 units on a scale
Standard Deviation 0.58
|
0.31 units on a scale
Standard Deviation 0.64
|
0.09 units on a scale
Standard Deviation 0.40
|
|
Individual Pain Intensity Differences (Ordinal)
30 minutes
|
0.94 units on a scale
Standard Deviation 0.76
|
1.03 units on a scale
Standard Deviation 0.74
|
0.73 units on a scale
Standard Deviation 0.80
|
0.95 units on a scale
Standard Deviation 0.83
|
0.15 units on a scale
Standard Deviation 0.56
|
|
Individual Pain Intensity Differences (Ordinal)
45 minutes
|
1.14 units on a scale
Standard Deviation 0.76
|
1.27 units on a scale
Standard Deviation 0.76
|
1.04 units on a scale
Standard Deviation 0.80
|
1.19 units on a scale
Standard Deviation 0.83
|
0.16 units on a scale
Standard Deviation 0.63
|
|
Individual Pain Intensity Differences (Ordinal)
60 minutes
|
1.31 units on a scale
Standard Deviation 0.85
|
1.48 units on a scale
Standard Deviation 0.79
|
1.24 units on a scale
Standard Deviation 0.87
|
1.35 units on a scale
Standard Deviation 0.85
|
0.22 units on a scale
Standard Deviation 0.79
|
|
Individual Pain Intensity Differences (Ordinal)
90 minutes
|
1.49 units on a scale
Standard Deviation 0.83
|
1.61 units on a scale
Standard Deviation 0.84
|
1.40 units on a scale
Standard Deviation 0.92
|
1.42 units on a scale
Standard Deviation 0.83
|
0.11 units on a scale
Standard Deviation 0.81
|
|
Individual Pain Intensity Differences (Ordinal)
3 hours
|
1.54 units on a scale
Standard Deviation 0.91
|
1.70 units on a scale
Standard Deviation 0.89
|
1.46 units on a scale
Standard Deviation 0.93
|
1.19 units on a scale
Standard Deviation 0.87
|
0.22 units on a scale
Standard Deviation 0.66
|
|
Individual Pain Intensity Differences (Ordinal)
4 hours
|
1.49 units on a scale
Standard Deviation 0.91
|
1.68 units on a scale
Standard Deviation 0.94
|
1.36 units on a scale
Standard Deviation 0.95
|
0.96 units on a scale
Standard Deviation 0.90
|
0.24 units on a scale
Standard Deviation 0.64
|
|
Individual Pain Intensity Differences (Ordinal)
5 hours
|
1.35 units on a scale
Standard Deviation 0.93
|
1.60 units on a scale
Standard Deviation 0.93
|
1.24 units on a scale
Standard Deviation 0.96
|
0.79 units on a scale
Standard Deviation 0.88
|
0.22 units on a scale
Standard Deviation 0.63
|
|
Individual Pain Intensity Differences (Ordinal)
6 hours
|
1.07 units on a scale
Standard Deviation 0.93
|
1.44 units on a scale
Standard Deviation 0.93
|
1.04 units on a scale
Standard Deviation 0.95
|
0.58 units on a scale
Standard Deviation 0.82
|
0.20 units on a scale
Standard Deviation 0.62
|
|
Individual Pain Intensity Differences (Ordinal)
7 hours
|
0.89 units on a scale
Standard Deviation 0.93
|
1.22 units on a scale
Standard Deviation 0.98
|
0.88 units on a scale
Standard Deviation 0.96
|
0.44 units on a scale
Standard Deviation 0.74
|
0.18 units on a scale
Standard Deviation 0.61
|
|
Individual Pain Intensity Differences (Ordinal)
8 hours
|
0.71 units on a scale
Standard Deviation 0.89
|
0.96 units on a scale
Standard Deviation 0.96
|
0.72 units on a scale
Standard Deviation 0.89
|
0.33 units on a scale
Standard Deviation 0.71
|
0.16 units on a scale
Standard Deviation 0.54
|
|
Individual Pain Intensity Differences (Ordinal)
9 hours
|
0.53 units on a scale
Standard Deviation 0.80
|
0.86 units on a scale
Standard Deviation 0.94
|
0.55 units on a scale
Standard Deviation 0.80
|
0.29 units on a scale
Standard Deviation 0.68
|
0.20 units on a scale
Standard Deviation 0.68
|
|
Individual Pain Intensity Differences (Ordinal)
10 hours
|
0.40 units on a scale
Standard Deviation 0.74
|
0.67 units on a scale
Standard Deviation 0.87
|
0.43 units on a scale
Standard Deviation 0.75
|
0.27 units on a scale
Standard Deviation 0.67
|
0.20 units on a scale
Standard Deviation 0.68
|
|
Individual Pain Intensity Differences (Ordinal)
11 hours
|
0.27 units on a scale
Standard Deviation 0.64
|
0.52 units on a scale
Standard Deviation 0.80
|
0.36 units on a scale
Standard Deviation 0.73
|
0.24 units on a scale
Standard Deviation 0.63
|
0.20 units on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hoursPopulation: ITT population
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.'
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
11 hours
|
9.4 units on a scale
Standard Deviation 21.2
|
18.7 units on a scale
Standard Deviation 27.2
|
12.8 units on a scale
Standard Deviation 24.7
|
9.8 units on a scale
Standard Deviation 23.2
|
6.2 units on a scale
Standard Deviation 20.1
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
15 minutes
|
9.0 units on a scale
Standard Deviation 13.7
|
10.5 units on a scale
Standard Deviation 16.3
|
4.5 units on a scale
Standard Deviation 14.1
|
8.7 units on a scale
Standard Deviation 16.6
|
0.4 units on a scale
Standard Deviation 13.1
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
30 minutes
|
22.8 units on a scale
Standard Deviation 21.4
|
26.2 units on a scale
Standard Deviation 21.5
|
17.7 units on a scale
Standard Deviation 22.5
|
23.9 units on a scale
Standard Deviation 23.9
|
2.2 units on a scale
Standard Deviation 16.7
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
45 minutes
|
32.5 units on a scale
Standard Deviation 23.8
|
37.5 units on a scale
Standard Deviation 24.0
|
28.3 units on a scale
Standard Deviation 25.7
|
34.3 units on a scale
Standard Deviation 25.7
|
0.9 units on a scale
Standard Deviation 18.8
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
60 minutes
|
40.3 units on a scale
Standard Deviation 25.5
|
46.3 units on a scale
Standard Deviation 24.4
|
36.6 units on a scale
Standard Deviation 28.7
|
41.5 units on a scale
Standard Deviation 27.1
|
1.8 units on a scale
Standard Deviation 19.3
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
90 minutes
|
48.3 units on a scale
Standard Deviation 25.8
|
52.5 units on a scale
Standard Deviation 24.8
|
43.7 units on a scale
Standard Deviation 28.2
|
44.6 units on a scale
Standard Deviation 25.9
|
0.9 units on a scale
Standard Deviation 22.6
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
2 hours
|
50.6 units on a scale
Standard Deviation 26.6
|
54.9 units on a scale
Standard Deviation 25.7
|
47.3 units on a scale
Standard Deviation 29.3
|
45.2 units on a scale
Standard Deviation 27.9
|
5.0 units on a scale
Standard Deviation 18.2
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
3 hours
|
51.0 units on a scale
Standard Deviation 27.1
|
55.9 units on a scale
Standard Deviation 25.5
|
48.0 units on a scale
Standard Deviation 29.3
|
38.9 units on a scale
Standard Deviation 29.9
|
6.1 units on a scale
Standard Deviation 21.3
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
4 hours
|
50.2 units on a scale
Standard Deviation 27.8
|
55.5 units on a scale
Standard Deviation 26.4
|
45.6 units on a scale
Standard Deviation 29.9
|
32.9 units on a scale
Standard Deviation 29.4
|
7.2 units on a scale
Standard Deviation 20.3
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
5 hours
|
45.4 units on a scale
Standard Deviation 28.7
|
52.8 units on a scale
Standard Deviation 26.7
|
42.5 units on a scale
Standard Deviation 30.4
|
25.9 units on a scale
Standard Deviation 29.2
|
7.2 units on a scale
Standard Deviation 19.8
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
6 hours
|
36.6 units on a scale
Standard Deviation 30.2
|
47.9 units on a scale
Standard Deviation 27.8
|
35.6 units on a scale
Standard Deviation 30.6
|
18.4 units on a scale
Standard Deviation 27.2
|
6.5 units on a scale
Standard Deviation 19.7
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
7 hours
|
30.9 units on a scale
Standard Deviation 30.6
|
41.0 units on a scale
Standard Deviation 29.8
|
29.7 units on a scale
Standard Deviation 30.8
|
15.4 units on a scale
Standard Deviation 25.2
|
5.8 units on a scale
Standard Deviation 18.8
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
8 hours
|
25.0 units on a scale
Standard Deviation 28.9
|
33.8 units on a scale
Standard Deviation 30.8
|
24.4 units on a scale
Standard Deviation 29.8
|
11.7 units on a scale
Standard Deviation 24.4
|
5.1 units on a scale
Standard Deviation 17.2
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
9 hours
|
17.7 units on a scale
Standard Deviation 26.4
|
29.6 units on a scale
Standard Deviation 30.3
|
18.4 units on a scale
Standard Deviation 27.2
|
10.8 units on a scale
Standard Deviation 22.9
|
5.6 units on a scale
Standard Deviation 19.4
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
10 hours
|
14.1 units on a scale
Standard Deviation 25.2
|
23.7 units on a scale
Standard Deviation 29.1
|
14.9 units on a scale
Standard Deviation 25.3
|
9.7 units on a scale
Standard Deviation 22.9
|
6.2 units on a scale
Standard Deviation 20.3
|
|
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
12 hours
|
8.0 units on a scale
Standard Deviation 20.4
|
15.1 units on a scale
Standard Deviation 25.5
|
11.0 units on a scale
Standard Deviation 22.9
|
9.3 units on a scale
Standard Deviation 22.1
|
6.4 units on a scale
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population
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.
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
|
1.78 units on a scale
Standard Deviation 0.83
|
1.93 units on a scale
Standard Deviation 0.81
|
1.74 units on a scale
Standard Deviation 0.87
|
1.63 units on a scale
Standard Deviation 0.77
|
0.60 units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population
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.
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Change From Baseline in Peak Pain Relief (PR)
|
3.06 units on a scale
Standard Deviation 1.00
|
3.25 units on a scale
Standard Deviation 0.89
|
2.98 units on a scale
Standard Deviation 1.11
|
2.88 units on a scale
Standard Deviation 1.00
|
0.96 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: At 12 hoursPopulation: Three subjects from ITT population were excluded from this analysis due to early/late diary assessments.
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.
Outcome measures
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=169 Participants
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=165 Participants
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=167 Participants
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 Participants
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 Participants
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
1 Poor
|
15 Participants
|
9 Participants
|
15 Participants
|
12 Participants
|
43 Participants
|
|
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
2 Fair
|
16 Participants
|
12 Participants
|
22 Participants
|
19 Participants
|
6 Participants
|
|
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
3 Good
|
43 Participants
|
32 Participants
|
40 Participants
|
41 Participants
|
2 Participants
|
|
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
4 Very good
|
72 Participants
|
69 Participants
|
64 Participants
|
34 Participants
|
3 Participants
|
|
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
5 Excellent
|
23 Participants
|
39 Participants
|
26 Participants
|
7 Participants
|
1 Participants
|
Adverse Events
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
Serious events: 0 serious events
Other events: 88 other events
Deaths: 0 deaths
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Nurofen Plus®
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
Panadeine® Extra
Serious events: 0 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)
n=173 participants at risk
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
|
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
n=168 participants at risk
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
|
Nurofen Plus®
n=169 participants at risk
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
|
Panadeine® Extra
n=113 participants at risk
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
|
Placebo
n=55 participants at risk
Two placebo tablets by mouth
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
24.9%
43/173 • Number of events 49 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
19.6%
33/168 • Number of events 36 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
29.6%
50/169 • Number of events 57 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
32.7%
37/113 • Number of events 49 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
32.7%
18/55 • Number of events 19 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
|
Gastrointestinal disorders
Vomiting
|
16.8%
29/173 • Number of events 32 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
17.9%
30/168 • Number of events 34 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
20.7%
35/169 • Number of events 41 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
22.1%
25/113 • Number of events 29 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
23.6%
13/55 • Number of events 13 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
|
Nervous system disorders
Dizziness
|
6.9%
12/173 • Number of events 13 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
8.9%
15/168 • Number of events 16 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
13.6%
23/169 • Number of events 24 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
12.4%
14/113 • Number of events 14 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
5.5%
3/55 • Number of events 4 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
|
Nervous system disorders
Headache
|
11.0%
19/173 • Number of events 23 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
11.3%
19/168 • Number of events 21 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
18.9%
32/169 • Number of events 35 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
18.6%
21/113 • Number of events 30 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
18.2%
10/55 • Number of events 11 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
|
Infections and infestations
Alveolar osteitis
|
4.6%
8/173 • Number of events 8 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
2.4%
4/168 • Number of events 4 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
5.3%
9/169 • Number of events 9 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
2.7%
3/113 • Number of events 3 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
1.8%
1/55 • Number of events 1 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
|
Investigations
Body temperature increased
|
1.2%
2/173 • Number of events 2 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
1.8%
3/168 • Number of events 3 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
5.3%
9/169 • Number of events 9 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
2.7%
3/113 • Number of events 3 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
1.8%
1/55 • Number of events 1 • Up to Day 10 (follow-up)
A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
|
Additional Information
Clinical Research Director, Clinical Research
Reckitt Benckiser Healthcare International
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator must submit any proposed manuscript to RB for approval prior to submission for publication. No timelines are stated. However, note that the results of this study have already been published.
- Publication restrictions are in place
Restriction type: OTHER