Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
Completed · Phase 2 · Has a placebo group
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01038609
- Run by
- AbbVie (prior sponsor, Abbott)
- People needed
- 250
- Starts
- 2009-12-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2014-04-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Site Reference ID/Investigator# 26223 — Peoria, Arizona, United States
- Site Reference ID/Investigator# 26302 — Austin, Texas, United States
- Site Reference ID/Investigator# 26303 — San Marcos, Texas, United States
- Site Reference ID/Investigator# 26304 — West Jordan, Utah, United States
Full record on ClinicalTrials.gov
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