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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00404391
First received: November 26, 2006
Last updated: January 14, 2011
Last verified: January 2011

November 26, 2006
January 14, 2011
October 2003
March 2004   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Pain relief measured by a 100mm Visual Analog Scale (VAS)
Time-interval-weighted sum of pain relief (TOTPAR) score for 0 to 12 hours following the first dose of study drug administration.
Complete list of historical versions of study NCT00404391 on ClinicalTrials.gov Archive Site
Time interval weighted sum of pain intensity difference (SPID)scores [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Sum of pain intensity difference
  • Time-interval-weighted sum of pain intensity difference (SPID) scores
  • Time interval weighted sum of pain relief and pain intensity difference (SPRID)
  • Time to first noticeable pain relief (i.e., onset of pain)
  • Time to first meaningful pain relief (i.e, 50% reduction in pain from baseline)
  • Time to rescue medication
  • Proportion of subjects experiencing meaningful pain relief after dosing
  • Mean pain relief and pain intensity at each scheduled pain evaluation
  • Subject Global Evaluation
Not Provided
Not Provided
 
A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Hydrocodone/Acetaminophen Extended Release
    1 tablet every 12 hours
    Other Names:
    • ABT-712
    • hydrocodone/acetaminophen extended release
  • Drug: Hydrocodone/Acetaminophen Extended Release
    2 tablets every 12 hours
    Other Names:
    • ABT-712
    • hydrocodone/acetaminophen extended release
  • Drug: Placebo
    2 tablets every 12 hours
    Other Name: placebo
  • Experimental: Arm 1: hydrocodone/acetaminophen extended release
    Intervention: Drug: Hydrocodone/Acetaminophen Extended Release
  • Experimental: Arm 2: hydrocodone/acetaminophen extended release
    Intervention: Drug: Hydrocodone/Acetaminophen Extended Release
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00404391
M03-609
No
Victor Jorden, MD, Abbott
Abbott
Not Provided
Study Director: Rita Jain, MD Abbott
Abbott
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP