Phase 2
Completed N=100
Acute Pain Study Following Bunionectomy
Source: ClinicalTrials.gov NCT01333722 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) — 259.0; 39.4 scores on a scale
Summary
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) |
259.0; 39.4 | — |
| SECONDARY TOTPAR (Total Pain Relief) |
15.4; 5.3 | — |
| SECONDARY SPRID (Pain Relief and Pain Intensity Difference) |
23.4; 7.2 | — |
| SECONDARY Time to Perceptible and Meaningful Pain Relief |
34.0; 56.0; 119.0; NA | — |
Eligibility Criteria
Inclusion Criteria
Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy
Exclusion Criteria
- Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy procedures
- Drug allergies to hydrocodone, acetaminophen
- Clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
Data sourced from ClinicalTrials.gov (NCT01333722). 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.