Phase 2
N=250
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01038609 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS) — 720.5; 239.9; 614.4; 450.8 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Hydrocodone/Acetaminophen Extended Release (Drug); Acetaminophen (Drug); Morphine Extended Release (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS) |
720.5; 239.9; 614.4; 450.8; -57.6 | — |
| SECONDARY TOTPAR (Total Pain Relief) |
65.9; 42.7; 49.5; 56.3; 32.9 | — |
| SECONDARY Participant's Global Assessment of Study Drug |
9; 8; 4; 7; 3; 15 | — |
| SECONDARY Time to Perceptible and Meaningful Pain Relief |
25.5; 32.0; 31.0; 22.5; 23.0; 62.5 | — |
| SECONDARY Participants With Adverse Events (AEs) |
28; 29; 28; 33; 28; 23 | — |
| SECONDARY Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria |
3; 6; 8; 2; 5; 1 | — |
| SECONDARY Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria |
1; 2; 3; 0; 0; 1 | — |
Summary
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.
Eligibility Criteria
Inclusion Criteria
- Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.
Exclusion Criteria
- Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
- Allergic reaction to study medications
- Pregnant or breastfeeding females
- Clinically significant lab abnormalities at screening
- Positive hepatitis testing at screening
- Clinically significant or uncontrolled medical disorders or illness at screening
- Active malignancy or chemotherapy
- Any history of drug or alcohol abuse/addiction
- Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
- History of major depressive episode or major psychiatric disorder
- Current systemic corticosteroid therapy
- Inability to refrain from smoking during or alcohol during stay at investigative site
Data sourced from ClinicalTrials.gov (NCT01038609). 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.