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Trial record 10 of 74 for:    Codeine AND Acetaminophen

Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study

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ClinicalTrials.gov Identifier: NCT01229449
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Premier Research Group plc
Aptuit Inc.
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-operative Pain
Interventions Drug: Ibuprofen/acetaminophen
Drug: Ibuprofen/acetaminophen (higher dose)
Drug: Nurofen Plus®
Drug: Panadeine® Extra
Drug: Placebo
Enrollment 678
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.
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth (single dose) Two tablets of ibuprofen 200 mg plus two tablets of acetaminophen 500 mg by mouth (single dose) Two tablets ibuprofen 200 mg plus codeine 12.8 mg (Nurofen Plus®) by mouth (single dose) Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth (single dose) Two placebo tablets by mouth
Period Title: Overall Study
Started 173 168 169 113 55
Completed 172 164 167 112 54
Not Completed 1 4 2 1 1
Reason Not Completed
Withdrawal by Subject             0             3             0             1             1
Lost to Follow-up             1             1             1             0             0
Physician Decision             0             0             1             0             0
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo Total
Hide Arm/Group Description One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth Two placebo tablets by mouth Total of all reporting groups
Overall Number of Baseline Participants 173 168 169 113 55 678
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
20.2  (3.3) 19.8  (3.2) 20.1  (3.4) 19.7  (3.3) 19.8  (3.6) 20.0  (3.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
Female
105
  60.7%
100
  59.5%
101
  59.8%
68
  60.2%
33
  60.0%
407
  60.0%
Male
68
  39.3%
68
  40.5%
68
  40.2%
45
  39.8%
22
  40.0%
271
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
American Indian or Alaska Native
0
   0.0%
1
   0.6%
2
   1.2%
0
   0.0%
0
   0.0%
3
   0.4%
Asian
3
   1.7%
4
   2.4%
7
   4.1%
1
   0.9%
2
   3.6%
17
   2.5%
Native Hawaiian or Other Pacific Islander
1
   0.6%
0
   0.0%
1
   0.6%
1
   0.9%
0
   0.0%
3
   0.4%
Black or African American
4
   2.3%
4
   2.4%
2
   1.2%
3
   2.7%
2
   3.6%
15
   2.2%
White
165
  95.4%
158
  94.0%
154
  91.1%
107
  94.7%
51
  92.7%
635
  93.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
3
   1.8%
1
   0.9%
0
   0.0%
5
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
173 168 169 113 55 678
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
68.1  (14.5) 69.0  (15.2) 68.8  (15.3) 70.8  (16.1) 71.0  (18.7) 69.2  (15.5)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
168.5  (10.0) 169.3  (10.1) 169.5  (9.8) 168.5  (9.7) 168.7  (9.5) 168.9  (9.9)
Drink alcohol  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
63 61 61 36 15 236
Former smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
27 23 20 13 9 92
Current smoker  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
16 16 16 14 5 67
Used drugs of abuse  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 173 participants 168 participants 169 participants 113 participants 55 participants 678 participants
32 31 37 18 8 126
1.Primary Outcome
Title Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
2.68  (1.59) 3.30  (1.67) 2.62  (1.73) 1.93  (1.51) 0.54  (1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Panadeine® Extra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Nurofen Plus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Panadeine® Extra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Nurofen Plus®
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Nurofen Plus®, Panadeine® Extra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Nurofen Plus®, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Panadeine® Extra, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in AUC (0-8h) of SPRID
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
0-4h 3.65  (1.60) 3.95  (1.52) 3.44  (1.72) 3.19  (1.61) 0.61  (1.26)
0-6h 3.66  (1.68) 4.06  (1.64) 3.45  (1.82) 2.86  (1.62) 0.60  (1.32)
0-8h 3.39  (1.71) 3.91  (1.69) 3.22  (1.85) 2.48  (1.57) 0.57  (1.31)
3.Secondary Outcome
Title Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
0-4h 1.32  (0.73) 1.46  (0.72) 1.23  (0.75) 1.13  (0.70) 0.18  (0.53)
0-6h 1.32  (0.74) 1.50  (0.75) 1.23  (0.76) 1.01  (0.67) 0.19  (0.53)
0-8h 1.21  (0.73) 1.43  (0.75) 1.14  (0.75) 0.87  (0.63) 0.19  (0.53)
0-12h 0.94  (0.64) 1.18  (0.69) 0.91  (0.67) 0.67  (0.57) 0.19  (0.56)
4.Secondary Outcome
Title Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
0-4h 2.33  (0.96) 2.48  (0.90) 2.20  (1.04) 2.05  (1.00) 0.42  (0.77)
0-6h 2.34  (1.02) 2.56  (0.98) 2.22  (1.12) 1.85  (1.03) 0.41  (0.82)
0-8h 2.18  (1.05) 2.48  (1.03) 2.08  (1.15) 1.61  (1.01) 0.38  (0.81)
0-12h 1.73  (1.01) 2.12  (1.06) 1.70  (1.11) 1.27  (0.98) 0.34  (0.82)
5.Secondary Outcome
Title Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
15 minutes 1.12  (1.21) 1.29  (1.38) 0.78  (1.22) 1.01  (1.40) 0.29  (0.74)
30 minutes 2.49  (1.63) 2.79  (1.62) 2.08  (1.71) 2.62  (1.83) 0.58  (1.13)
45 minutes 3.20  (1.72) 3.52  (1.64) 2.92  (1.84) 3.39  (1.80) 0.65  (1.38)
60 minutes 3.71  (1.83) 4.04  (1.66) 3.49  (1.98) 3.81  (1.83) 0.71  (1.49)
90 minutes 4.12  (1.82) 4.44  (1.69) 3.92  (2.06) 3.96  (1.77) 0.60  (1.56)
2 hours 4.28  (1.95) 4.51  (1.80) 4.17  (2.14) 3.91  (1.90) 0.67  (1.43)
3 hours 4.18  (2.06) 4.53  (1.95) 4.02  (2.14) 3.31  (2.13) 1.66  (0.00)
4 hours 4.08  (2.09) 4.46  (2.09) 3.78  (2.31) 2.79  (2.21) 0.64  (1.65)
5 hours 3.77  (2.21) 4.36  (2.12) 3.52  (2.40) 2.23  (2.20) 0.60  (1.59)
6 hours 3.06  (2.34) 3.98  (2.24) 2.98  (2.47) 1.70  (2.16) 0.53  (1.56)
7 hours 2.56  (2.37) 3.51  (2.40) 2.54  (2.50) 1.31  (2.00) 0.45  (1.45)
8 hours 2.09  (2.31) 2.79  (2.49) 2.08  (2.38) 1.02  (1.92) 0.40  (1.30)
9 hours 1.57  (2.20) 2.53  (2.47) 1.68  (2.20) 0.91  (1.87) 0.47  (1.59)
10 hours 1.21  (2.02) 2.04  (2.34) 1.30  (2.06) 0.81  (1.84) 0.49  (1.62)
11 hours 0.90  (1.83) 1.63  (2.24) 1.12  (2.02) 0.76  (1.77) 0.49  (1.62)
12 hours 0.69  (1.64) 1.34  (2.14) 0.96  (1.85) 0.74  (1.76) 0.49  (1.62)
6.Secondary Outcome
Title Individual Pain Intensity Differences (Ordinal)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
15 minutes 0.40  (0.57) 0.46  (0.64) 0.23  (0.58) 0.31  (0.64) 0.09  (0.40)
30 minutes 0.94  (0.76) 1.03  (0.74) 0.73  (0.80) 0.95  (0.83) 0.15  (0.56)
45 minutes 1.14  (0.76) 1.27  (0.76) 1.04  (0.80) 1.19  (0.83) 0.16  (0.63)
60 minutes 1.31  (0.85) 1.48  (0.79) 1.24  (0.87) 1.35  (0.85) 0.22  (0.79)
90 minutes 1.49  (0.83) 1.61  (0.84) 1.40  (0.92) 1.42  (0.83) 0.11  (0.81)
2 hours 1.54  (0.89) 1.69  (0.87) 1.52  (0.94) 1.41  (0.84) 0.24  (0.54)
3 hours 1.54  (0.91) 1.70  (0.89) 1.46  (0.93) 1.19  (0.87) 0.22  (0.66)
4 hours 1.49  (0.91) 1.68  (0.94) 1.36  (0.95) 0.96  (0.90) 0.24  (0.64)
5 hours 1.35  (0.93) 1.60  (0.93) 1.24  (0.96) 0.79  (0.88) 0.22  (0.63)
6 hours 1.07  (0.93) 1.44  (0.93) 1.04  (0.95) 0.58  (0.82) 0.20  (0.62)
7 hours 0.89  (0.93) 1.22  (0.98) 0.88  (0.96) 0.44  (0.74) 0.18  (0.61)
8 hours 0.71  (0.89) 0.96  (0.96) 0.72  (0.89) 0.33  (0.71) 0.16  (0.54)
9 hours 0.53  (0.80) 0.86  (0.94) 0.55  (0.80) 0.29  (0.68) 0.20  (0.68)
10 hours 0.40  (0.74) 0.67  (0.87) 0.43  (0.75) 0.27  (0.67) 0.20  (0.68)
11 hours 0.27  (0.64) 0.52  (0.80) 0.36  (0.73) 0.24  (0.63) 0.20  (0.68)
12 hours 0.21  (0.57) 0.42  (0.78) 0.30  (0.63) 0.25  (0.63) 0.20  (0.68)
7.Secondary Outcome
Title Individual Pain Intensity Differences Visual Analogue Scale (VAS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
15 minutes 9.0  (13.7) 10.5  (16.3) 4.5  (14.1) 8.7  (16.6) 0.4  (13.1)
30 minutes 22.8  (21.4) 26.2  (21.5) 17.7  (22.5) 23.9  (23.9) 2.2  (16.7)
45 minutes 32.5  (23.8) 37.5  (24.0) 28.3  (25.7) 34.3  (25.7) 0.9  (18.8)
60 minutes 40.3  (25.5) 46.3  (24.4) 36.6  (28.7) 41.5  (27.1) 1.8  (19.3)
90 minutes 48.3  (25.8) 52.5  (24.8) 43.7  (28.2) 44.6  (25.9) 0.9  (22.6)
2 hours 50.6  (26.6) 54.9  (25.7) 47.3  (29.3) 45.2  (27.9) 5.0  (18.2)
3 hours 51.0  (27.1) 55.9  (25.5) 48.0  (29.3) 38.9  (29.9) 6.1  (21.3)
4 hours 50.2  (27.8) 55.5  (26.4) 45.6  (29.9) 32.9  (29.4) 7.2  (20.3)
5 hours 45.4  (28.7) 52.8  (26.7) 42.5  (30.4) 25.9  (29.2) 7.2  (19.8)
6 hours 36.6  (30.2) 47.9  (27.8) 35.6  (30.6) 18.4  (27.2) 6.5  (19.7)
7 hours 30.9  (30.6) 41.0  (29.8) 29.7  (30.8) 15.4  (25.2) 5.8  (18.8)
8 hours 25.0  (28.9) 33.8  (30.8) 24.4  (29.8) 11.7  (24.4) 5.1  (17.2)
9 hours 17.7  (26.4) 29.6  (30.3) 18.4  (27.2) 10.8  (22.9) 5.6  (19.4)
10 hours 14.1  (25.2) 23.7  (29.1) 14.9  (25.3) 9.7  (22.9) 6.2  (20.3)
11 hours 9.4  (21.2) 18.7  (27.2) 12.8  (24.7) 9.8  (23.2) 6.2  (20.1)
12 hours 8.0  (20.4) 15.1  (25.5) 11.0  (22.9) 9.3  (22.1) 6.4  (20.8)
8.Secondary Outcome
Title Change From Baseline in Peak Pain Intensity Difference (Peak PID – Ordinal)
Hide Description

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
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Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.78  (0.83) 1.93  (0.81) 1.74  (0.87) 1.63  (0.77) 0.60  (0.87)
9.Secondary Outcome
Title Change From Baseline in Peak Pain Relief (PR)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 173 168 169 113 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.06  (1.00) 3.25  (0.89) 2.98  (1.11) 2.88  (1.00) 0.96  (1.15)
10.Secondary Outcome
Title Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Three subjects from ITT population were excluded from this analysis due to early/late diary assessments.
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description:
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth
Two placebo tablets by mouth
Overall Number of Participants Analyzed 169 165 167 113 55
Measure Type: Count of Participants
Unit of Measure: Participants
1 Poor
15
   8.9%
9
   5.5%
15
   9.0%
12
  10.6%
43
  78.2%
2 Fair
16
   9.5%
12
   7.3%
22
  13.2%
19
  16.8%
6
  10.9%
3 Good
43
  25.4%
32
  19.4%
40
  24.0%
41
  36.3%
2
   3.6%
4 Very good
72
  42.6%
69
  41.8%
64
  38.3%
34
  30.1%
3
   5.5%
5 Excellent
23
  13.6%
39
  23.6%
26
  15.6%
7
   6.2%
1
   1.8%
Time Frame Up to Day 10 (follow-up)
Adverse Event Reporting Description A treatment emergent adverse event is any event commencing within 12 hours of study medication dose.
 
Arm/Group Title Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Hide Arm/Group Description One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet by mouth Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg by mouth Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) by mouth Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) by mouth Two placebo tablets by mouth
All-Cause Mortality
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/173 (0.00%)      0/168 (0.00%)      0/169 (0.00%)      0/113 (0.00%)      0/55 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/173 (0.00%)      0/168 (0.00%)      0/169 (0.00%)      0/113 (0.00%)      0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) Nurofen Plus® Panadeine® Extra Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/173 (50.87%)      87/168 (51.79%)      97/169 (57.40%)      72/113 (63.72%)      35/55 (63.64%)    
Gastrointestinal disorders           
Nausea  1  43/173 (24.86%)  49 33/168 (19.64%)  36 50/169 (29.59%)  57 37/113 (32.74%)  49 18/55 (32.73%)  19
Vomiting  1  29/173 (16.76%)  32 30/168 (17.86%)  34 35/169 (20.71%)  41 25/113 (22.12%)  29 13/55 (23.64%)  13
Infections and infestations           
Alveolar osteitis  1  8/173 (4.62%)  8 4/168 (2.38%)  4 9/169 (5.33%)  9 3/113 (2.65%)  3 1/55 (1.82%)  1
Investigations           
Body temperature increased  1  2/173 (1.16%)  2 3/168 (1.79%)  3 9/169 (5.33%)  9 3/113 (2.65%)  3 1/55 (1.82%)  1
Nervous system disorders           
Dizziness  2  12/173 (6.94%)  13 15/168 (8.93%)  16 23/169 (13.61%)  24 14/113 (12.39%)  14 3/55 (5.45%)  4
Headache  1  19/173 (10.98%)  23 19/168 (11.31%)  21 32/169 (18.93%)  35 21/113 (18.58%)  30 10/55 (18.18%)  11
1
Term from vocabulary, MedDRA 12.1
2
Term from vocabulary, undefined
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Director, Clinical Research
Organization: Reckitt Benckiser Healthcare International
EMail: clinicalrequests@rb.com
Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01229449     History of Changes
Other Study ID Numbers: NL0811
First Submitted: October 26, 2010
First Posted: October 27, 2010
Results First Submitted: July 11, 2011
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018