Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Sponsor
Reckitt Benckiser LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01229449
Collaborator
Premier Research Group plc (Industry), Aptuit Inc. (Industry)
678
1
5
8
84.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
678 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Sep 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ibuprofen/acetaminophen (lower dose) One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet |
Drug: Ibuprofen/acetaminophen
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
Other Names:
|
| Experimental: Ibuprofen/acetaminophen (higher dose) Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg |
Drug: Ibuprofen/acetaminophen (higher dose)
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
Other Names:
|
| Active Comparator: Nurofen Plus® Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) |
Drug: Nurofen Plus®
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
Other Names:
|
| Active Comparator: Panadeine® Extra Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) |
Drug: Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
Other Names:
|
| Placebo Comparator: Placebo Two placebo tablets |
Drug: Placebo
Two placebo tablets, single dose taken orally with 300 ml water
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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.'
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
16 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Premier Research | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Reckitt Benckiser LLC
- Premier Research Group plc
- Aptuit Inc.
Investigators
- Principal Investigator: Stephen Daniels, Premier Research Group Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01229449
Other Study ID Numbers:
- NL0811
First Posted:
Oct 27, 2010
Last Update Posted:
Sep 17, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Reckitt Benckiser LLC
Additional relevant MeSH terms:
Study Results
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 Detail | 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 |
|---|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | Nurofen Plus® | Panadeine® Extra | Placebo | Total |
|---|---|---|---|---|---|---|
| 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 Participants | 173 | 168 | 169 | 113 | 55 | 678 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
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 (Count of Participants) | ||||||
| Female |
105
60.7%
|
100
59.5%
|
101
59.8%
|
68
60.2%
|
33
60%
|
407
60%
|
| Male |
68
39.3%
|
68
40.5%
|
68
40.2%
|
45
39.8%
|
22
40%
|
271
40%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
1
0.6%
|
2
1.2%
|
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%
|
1
0.6%
|
1
0.9%
|
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%
|
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%
|
| Unknown or Not Reported |
0
0%
|
1
0.6%
|
3
1.8%
|
1
0.9%
|
0
0%
|
5
0.7%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
173
100%
|
168
100%
|
169
100%
|
113
100%
|
55
100%
|
678
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [kg] |
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 (cm) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [cm] |
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 (participants) [Number] | ||||||
| Number [participants] |
63
36.4%
|
61
36.3%
|
61
36.1%
|
36
31.9%
|
15
27.3%
|
236
34.8%
|
| Former smoker (participants) [Number] | ||||||
| Number [participants] |
27
15.6%
|
23
13.7%
|
20
11.8%
|
13
11.5%
|
9
16.4%
|
92
13.6%
|
| Current smoker (participants) [Number] | ||||||
| Number [participants] |
16
9.2%
|
16
9.5%
|
16
9.5%
|
14
12.4%
|
5
9.1%
|
67
9.9%
|
| Used drugs of abuse (participants) [Number] | ||||||
| Number [participants] |
32
18.5%
|
31
18.5%
|
37
21.9%
|
18
15.9%
|
8
14.5%
|
126
18.6%
|
Outcome Measures
| Title | Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| Mean (Standard Deviation) [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)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Panadeine® Extra |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose), Nurofen Plus® |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Panadeine® Extra |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Nurofen Plus® |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.72 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose), Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Nurofen Plus®, Panadeine® Extra |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0005 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Nurofen Plus®, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Panadeine® Extra, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Change From Baseline in AUC (0-8h) of SPRID |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Individual Pain Intensity Differences (Ordinal) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Individual Pain Intensity Differences Visual Analogue Scale (VAS) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| 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)
|
| Title | Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| Mean (Standard Deviation) [units on a scale] |
1.78
(0.83)
|
1.93
(0.81)
|
1.74
(0.87)
|
1.63
(0.77)
|
0.60
(0.87)
|
| Title | Change From Baseline in Peak Pain Relief (PR) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 173 | 168 | 169 | 113 | 55 |
| Mean (Standard Deviation) [units on a scale] |
3.06
(1.00)
|
3.25
(0.89)
|
2.98
(1.11)
|
2.88
(1.00)
|
0.96
(1.15)
|
| Title | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|---|
| 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 |
| Measure Participants | 169 | 165 | 167 | 113 | 55 |
| 1 Poor |
15
8.7%
|
9
5.4%
|
15
8.9%
|
12
10.6%
|
43
78.2%
|
| 2 Fair |
16
9.2%
|
12
7.1%
|
22
13%
|
19
16.8%
|
6
10.9%
|
| 3 Good |
43
24.9%
|
32
19%
|
40
23.7%
|
41
36.3%
|
2
3.6%
|
| 4 Very good |
72
41.6%
|
69
41.1%
|
64
37.9%
|
34
30.1%
|
3
5.5%
|
| 5 Excellent |
23
13.3%
|
39
23.2%
|
26
15.4%
|
7
6.2%
|
1
1.8%
|
Adverse Events
| 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 | |||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/173 (0%) | 0/168 (0%) | 0/169 (0%) | 0/113 (0%) | 0/55 (0%) | |||||
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%) | 0/168 (0%) | 0/169 (0%) | 0/113 (0%) | 0/55 (0%) | |||||
Other (Not Including 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 | 88/173 (50.9%) | 87/168 (51.8%) | 97/169 (57.4%) | 72/113 (63.7%) | 35/55 (63.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 43/173 (24.9%) | 49 | 33/168 (19.6%) | 36 | 50/169 (29.6%) | 57 | 37/113 (32.7%) | 49 | 18/55 (32.7%) | 19 |
| Vomiting | 29/173 (16.8%) | 32 | 30/168 (17.9%) | 34 | 35/169 (20.7%) | 41 | 25/113 (22.1%) | 29 | 13/55 (23.6%) | 13 |
| Infections and infestations | ||||||||||
| Alveolar osteitis | 8/173 (4.6%) | 8 | 4/168 (2.4%) | 4 | 9/169 (5.3%) | 9 | 3/113 (2.7%) | 3 | 1/55 (1.8%) | 1 |
| Investigations | ||||||||||
| Body temperature increased | 2/173 (1.2%) | 2 | 3/168 (1.8%) | 3 | 9/169 (5.3%) | 9 | 3/113 (2.7%) | 3 | 1/55 (1.8%) | 1 |
| Nervous system disorders | ||||||||||
| Dizziness | 12/173 (6.9%) | 13 | 15/168 (8.9%) | 16 | 23/169 (13.6%) | 24 | 14/113 (12.4%) | 14 | 3/55 (5.5%) | 4 |
| Headache | 19/173 (11%) | 23 | 19/168 (11.3%) | 21 | 32/169 (18.9%) | 35 | 21/113 (18.6%) | 30 | 10/55 (18.2%) | 11 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Clinical Research Director, Clinical Research |
|---|---|
| Organization | Reckitt Benckiser Healthcare International |
| Phone | |
| clinicalrequests@rb.com |
Responsible Party:
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01229449
Other Study ID Numbers:
- NL0811
First Posted:
Oct 27, 2010
Last Update Posted:
Sep 17, 2018
Last Verified:
Aug 1, 2018