Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Morphine; Oxycodone

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