Phase 2
Completed N=122
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Source: ClinicalTrials.gov NCT00935311 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) — 268.8; 230.9; 54.8 scores on a scale
Summary
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) |
268.8; 230.9; 54.8 | — |
| SECONDARY TOTPAR (Total Pain Relief) |
18.0; 15.9; 10.5 | — |
| SECONDARY Time to First Rescue Medication |
442.0; 205.0; 123.5 | — |
| SECONDARY Participants With Adverse Events (AEs) |
14; 12; 14; 5; 8; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures
Exclusion Criteria
- Allergies to study medications
- History of multiple drug allergies
- Unable to stop excluded medications
- Clinically significant laboratory abnormalities at Screening
- Significant medical condition at Screening
- Women who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00935311). 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.