Phase 2
N=100
Acute Pain Study Following Bunionectomy
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01333722 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS) — 259.0; 39.4 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydrocodone/Acetaminophen Extended Release (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Jun 2011
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 | — |
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.
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.