Back to resultsIbuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen/acetaminophen
Ibuprofen/acetaminophen (higher dose)
Nurofen Plus®
Panadeine® Extra
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Dental pain, Ibuprofen, Acetaminophen, Nurofen Plus®, Panadeine® Extra, Paracetamol
Eligibility Criteria
Main Inclusion Criteria:
Experiencing moderate to severe pain after extraction of impacted third molars
Main Exclusion Criteria:
Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
Sites / Locations
- Premier Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Ibuprofen/acetaminophen (lower dose)
Ibuprofen/acetaminophen (higher dose)
Nurofen Plus®
Panadeine® Extra
Placebo
Arm Description
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
Two placebo tablets
Outcomes
Primary Outcome Measures
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Secondary Outcome Measures
Change From Baseline in AUC (0-8h) of SPRID
SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'
Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.
Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'
Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
Individual Pain Intensity Differences (Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'
PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Individual Pain Intensity Differences Visual Analogue Scale (VAS)
Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.'
Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'
PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain.
Change From Baseline in Peak Pain Relief (PR)
Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'
Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete.
Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?'
Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent.
Full Information
NCT ID
NCT01229449
First Posted
October 26, 2010
Last Updated
August 14, 2018
Sponsor
Reckitt Benckiser LLC
Collaborators
Premier Research Group plc, Aptuit
1. Study Identification
Unique Protocol Identification Number
NCT01229449
Brief Title
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser LLC
Collaborators
Premier Research Group plc, Aptuit
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Dental pain, Ibuprofen, Acetaminophen, Nurofen Plus®, Panadeine® Extra, Paracetamol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
678 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen/acetaminophen (lower dose)
Arm Type
Experimental
Arm Description
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
Arm Title
Ibuprofen/acetaminophen (higher dose)
Arm Type
Experimental
Arm Description
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
Arm Title
Nurofen Plus®
Arm Type
Active Comparator
Arm Description
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
Arm Title
Panadeine® Extra
Arm Type
Active Comparator
Arm Description
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo tablets
Intervention Type
Drug
Intervention Name(s)
Ibuprofen/acetaminophen
Other Intervention Name(s)
Ibuprofen/paracetamol (lower dose)
Intervention Description
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
Intervention Type
Drug
Intervention Name(s)
Ibuprofen/acetaminophen (higher dose)
Other Intervention Name(s)
Ibuprofen/Paracetamol
Intervention Description
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
Intervention Type
Drug
Intervention Name(s)
Nurofen Plus®
Other Intervention Name(s)
Ibuprofen/Codeine
Intervention Description
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
Intervention Type
Drug
Intervention Name(s)
Panadeine® Extra
Other Intervention Name(s)
Acetaminophen/codeine, Paracetamol/codeine
Intervention Description
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two placebo tablets, single dose taken orally with 300 ml water
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Experiencing moderate to severe pain after extraction of impacted third molars
Main Exclusion Criteria:
Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Daniels
Organizational Affiliation
Premier Research Group Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Premier Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
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