Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

Official Title: “Phase 2 Acute Pain Bunionectomy”

The primary purpose of this study is to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

Intervention(s) in this Clinical Trial

• Drug: Hydrocodone/acetaminophen extended release
  • 1 tablet every 12 hours
• Drug: Morphine Extended Release
  • 1 capsule every 12 hours
• Drug: Acetaminophen
  • 1 tablet every 6 hours
• Drug: Placebo
  • 1 tablet every 6 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Hydrocodone/acetaminophen extended release
• Active Comparator: Morphine Extended Release
• Active Comparator: Acetaminophen
• Active Comparator: Morphine Extended Release and Acetaminophen
• Placebo Comparator: Placebo

Primary Measures

• Time-interval weighted Sum of Pain Intensity Difference (SPID)
  • Time Frame: 48 hours
    Safety Issue?: No

Secondary Measures

• Time-interval weighted sum of pain relief (TOTPAR)
  • Time Frame: 48 hours
    Safety Issue?: No
• Subject's global assessment of study drug
  • Time Frame: 48 hours
    Safety Issue?: No
• Assessment of perceptible and meaningful pain relief
  • Time Frame: 12 hours
    Safety Issue?: No
• Adverse events,vital signs, laboratory parameters
  • Time Frame: 48 hours
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects who are in general good health, experiencing moderate to severe pain following bunionectomy surgery and who are willing to remain confined until for approximately 4 days following surgery for study procedures.

Exclusion Criteria:

• Subjects who undergo 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 HIV; requires treatment with MAOIs, 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Abbott Industry

Overall Clinical Trial Officials and Contacts

Jerry A Hall, MD Study Director Abbott  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01038609

Study ID Number: M12-058

ClinicalTrials.gov Identifier: NCT01038609

Health Authority: United States: Food and Drug Administration