Phase 3
Completed N=678
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain Study
Post-operative Pain
Source: ClinicalTrials.gov NCT01229449 ↗
Enrolled (actual)
678
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) — 2.68; 3.30; 2.62; 1.93 units on a scale*hour — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID) |
2.68; 3.30; 2.62; 1.93; 0.54 | <0.0001 sig |
| SECONDARY Change From Baseline in AUC (0-8h) of SPRID |
3.65; 3.95; 3.44; 3.19; 0.61; 3.66 | — |
| SECONDARY Change From Baseline in AUC for Pain Intensity Difference Scores (SPID) |
1.32; 1.46; 1.23; 1.13; 0.18; 1.32 | — |
| SECONDARY Change From Baseline in AUC of Pain Relief Scores (TOTPAR) |
2.33; 2.48; 2.20; 2.05; 0.42; 2.34 | — |
| SECONDARY Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID) |
1.12; 1.29; 0.78; 1.01; 0.29; 2.49 | — |
| SECONDARY Individual Pain Intensity Differences (Ordinal) |
0.40; 0.46; 0.23; 0.31; 0.09; 0.94 | — |
| SECONDARY Individual Pain Intensity Differences Visual Analogue Scale (VAS) |
9.0; 10.5; 4.5; 8.7; 0.4; 22.8 | — |
| SECONDARY Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal) |
1.78; 1.93; 1.74; 1.63; 0.60 | — |
| SECONDARY Change From Baseline in Peak Pain Relief (PR) |
3.06; 3.25; 2.98; 2.88; 0.96 | — |
| SECONDARY Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication |
15; 9; 15; 12; 43; 16 | — |
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
Data sourced from ClinicalTrials.gov (NCT01229449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.