Trial · NCT01229449
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
NCT01229449, Phase 3, Completed, Reckitt Benckiser LLC; results first posted 2018-09-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study. Trials, record NCT01229449. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01229449
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
- NCT number
- NCT01229449
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 678 participants, actual
- Lead sponsor
- Reckitt Benckiser LLC
- Conditions
- Post-operative Pain
- Interventions
- Ibuprofen/acetaminophen, Ibuprofen/acetaminophen (higher dose), Nurofen Plus®, Panadeine® Extra, Placebo
- First posted
- 2010-10-27
- Last updated
- 2018-09-17
- Results first posted
- 2018-09-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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?' |
| Secondary | 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?' |
| Secondary | 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. |
| Secondary | 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?' |
| Secondary | 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. |
| Secondary | 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.' |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | units on a scale*hour | MEAN |
| SECONDARY | 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 | ITT population | units on a scale*hour | MEAN |
| SECONDARY | Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) | 0-4, 0-6, 0-8 and 0-12 hours | ITT population | units on a scale*hour | MEAN |
| SECONDARY | Change From Baseline in AUC of Pain Relief Scores (TOTPAR) | 0-4, 0-6, 0-8 and 0-12 hours | ITT population | units on a scale*hour | MEAN |
| SECONDARY | 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 | ITT population | units on a scale | MEAN |
| SECONDARY | 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 | ITT population | units on a scale | MEAN |
| SECONDARY | 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 | ITT population | units on a scale | MEAN |
| SECONDARY | 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 | ITT population | units on a scale | MEAN |
| SECONDARY | 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 | ITT population | units on a scale | MEAN |
| SECONDARY | Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication | At 12 hours | Three subjects from ITT population were excluded from this analysis due to early/late diary assessments. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group335
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 2.68 | Standard Deviation 1.59 | units on a scale*hour | |
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 3.30 | Standard Deviation 1.67 | units on a scale*hour | |
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | Nurofen Plus® | 2.62 | Standard Deviation 1.73 | units on a scale*hour | |
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | Panadeine® Extra | 1.93 | Standard Deviation 1.51 | units on a scale*hour | |
| Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) | Placebo | 0.54 | Standard Deviation 1.37 | units on a scale*hour | |
| Change From Baseline in AUC (0-8h) of SPRID | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 0-4h | 3.65 | Standard Deviation 1.60 | units on a scale*hour |
| Change From Baseline in AUC (0-8h) of SPRID | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 0-4h | 3.95 | Standard Deviation 1.52 | units on a scale*hour |
| Change From Baseline in AUC (0-8h) of SPRID | Nurofen Plus® | 0-4h | 3.44 | Standard Deviation 1.72 | units on a scale*hour |
| Change From Baseline in AUC (0-8h) of SPRID | Panadeine® Extra | 0-4h | 3.19 | Standard Deviation 1.61 | units on a scale*hour |
| Change From Baseline in AUC (0-8h) of SPRID | Placebo | 0-4h | 0.61 | Standard Deviation 1.26 | units on a scale*hour |
1 to 10 of 335Source ClinicalTrials.gov
See all 335 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 173 | |
| Overall Study | STARTED | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 168 | |
| Overall Study | STARTED | Nurofen Plus® | 169 | |
| Overall Study | STARTED | Panadeine® Extra | 113 | |
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | COMPLETED | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 172 | |
| Overall Study | COMPLETED | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 164 | |
| Overall Study | COMPLETED | Nurofen Plus® | 167 | |
| Overall Study | COMPLETED | Panadeine® Extra | 112 | |
| Overall Study | COMPLETED | Placebo | 54 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 43 | 173 | 49 |
| other | Nausea | Gastrointestinal disorders | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 33 | 168 | 36 |
| other | Nausea | Gastrointestinal disorders | Nurofen Plus® | 50 | 169 | 57 |
| other | Nausea | Gastrointestinal disorders | Panadeine® Extra | 37 | 113 | 49 |
| other | Nausea | Gastrointestinal disorders | Placebo | 18 | 55 | 19 |
| other | Vomiting | Gastrointestinal disorders | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 29 | 173 | 32 |
| other | Vomiting | Gastrointestinal disorders | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 30 | 168 | 34 |
| other | Vomiting | Gastrointestinal disorders | Nurofen Plus® | 35 | 169 | 41 |
| other | Vomiting | Gastrointestinal disorders | Panadeine® Extra | 25 | 113 | 29 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 13 | 55 | 13 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 0 | 173 |
| Total, all-cause mortality | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 0 | 168 |
| Total, all-cause mortality | Nurofen Plus® | 0 | 169 |
| Total, all-cause mortality | Panadeine® Extra | 0 | 113 |
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, other adverse events | Ibuprofen 200mg + Paracetamol 500mg (Lower Dose) | 88 | 173 |
| Total, other adverse events | Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose) | 87 | 168 |
| Total, other adverse events | Nurofen Plus® | 97 | 169 |
| Total, other adverse events | Panadeine® Extra | 72 | 113 |
| Total, other adverse events | Placebo | 35 | 55 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01229449
GET https://conductscience.org/api/trials/v1/NCT01229449/results?page=2