Phase 2
Completed N=394
Evaluation of the Efficacy of Novel Ibuprofen Acetaminophen Combination Formulations in the Treatment of Post-surgical Dental Pain
Source: ClinicalTrials.gov NCT01559259 ↗Enrolled (actual)
394
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) — 5.0; 30.8; 29.6; 31.7 units on a scale — p=<0.001
Summary
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8) |
5.0; 30.8; 29.6; 31.7; 28.8 | <0.001 sig |
| SECONDARY Time to Onset of Meaningful Pain Relief |
NA; 44.5; 54.1; 45.9; 56.2 | <0.001 sig |
| SECONDARY Time to Confirmed First Perceptible Relief |
NA; 18.5; 22.8; 18.5; 24.9 | <0.001 sig |
| SECONDARY Pain Relief Rating Score (PRR) |
0.2; 0.6; 0.5; 0.7; 0.4; 0.3 | 0.014 sig |
| SECONDARY Pain Intensity Difference on 4-Point Categorical Scale (PID4) |
0.1; 0.3; 0.2; 0.3; 0.2; 0.1 | 0.033 sig |
| SECONDARY Pain Intensity Difference on 11-Point Numerical Scale (PID11) |
0.1; 1.0; 0.8; 0.9; 0.4; 0.2 | 0.006 sig |
| SECONDARY Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4) |
0.3; 1.0; 0.7; 1.0; 0.6; 0.3 | 0.014 sig |
| SECONDARY Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose |
0.1; 2.7; 2.4; 2.7; 2.2; 0.7 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose |
0.1; 8.8; 8.0; 8.6; 7.2; 1.1 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose |
0.7; 4.7; 4.3; 4.7; 4.0; 2.8 | <0.001 sig |
| SECONDARY Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose |
0.9; 7.4; 6.7; 7.4; 6.2; 3.5 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Meaningful Relief |
0.0; 1.1; 1.1; 3.4; 1.1; 0.0 | 0.571 |
| SECONDARY Cumulative Percentage of Participants With Confirmed First Perceptible Relief |
3.3; 26.7; 18.3; 28.1; 19.6; 10.0 | 0.003 sig |
| SECONDARY Time to Treatment Failure |
1.6; 9.7; 10.1; 11.1; 10.4 | <0.001 sig |
| SECONDARY Cumulative Percentage of Participants With Treatment Failure |
43.3; 2.2; 2.2; 4.5; 5.4; 73.3 | <0.001 sig |
| SECONDARY Participant Global Evaluation of Study Medication |
1.0; 3.8; 3.4; 3.6; 3.5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Males and females 16 to 40 years of age
- Moderate to severe post-operative pain following surgical extraction of three or more third molar teeth
Exclusion Criteria
- Presence of history of significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorder
- Pregnant or breastfeeding females
Data sourced from ClinicalTrials.gov (NCT01559259). 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.