A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

Overview

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2004

Interventions

  • Drug: Hydrocodone/Acetaminophen Extended Release
    • 1 tablet every 12 hours
  • Drug: Hydrocodone/Acetaminophen Extended Release
    • 2 tablets every 12 hours
  • Drug: Placebo
    • 2 tablets every 12 hours

Arms, Groups and Cohorts

  • Experimental: Arm 1: hydrocodone/acetaminophen extended release
  • Experimental: Arm 2: hydrocodone/acetaminophen extended release
  • Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

  • Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
    • Time Frame: 12 hours
    • Pain relief measured by a 100mm Visual Analog Scale (VAS)

Secondary Measures

  • Time interval weighted sum of pain intensity difference (SPID)scores
    • Time Frame: 12 hours
    • Sum of pain intensity difference

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female ages 18 to 65 – Females must be of non-childbearing potential or practicing birth control – Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery Exclusion Criteria:

  • Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs – Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study – Is associated with any currently ongoing research study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott
  • Provider of Information About this Clinical Study
    • Victor Jorden, MD, Abbott
  • Overall Official(s)
    • Rita Jain, MD, Study Director, Abbott

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