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A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00402792
First received: November 20, 2006
Last updated: January 24, 2011
Last verified: January 2011
History of Changes

November 20, 2006
January 24, 2011
December 2006
April 2007   (final data collection date for primary outcome measure)
Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Sum of pain intensity difference using a 100 mm Visual Analog Scale (VAS)
Time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hour interval following study drug administration.
Complete list of historical versions of study NCT00402792 on ClinicalTrials.gov Archive Site
  • Time-interval weighted sum of pain relief (TOTPAR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time-interval weighted sum of pain relief and pain intensity difference (SPRID) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Perceptible pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Meaningful pain relief [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Pain relief (PR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Pain intensity (PI) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time-interval weighted sum of pain relief (TOTPAR)
  • Time-interval weighted sum of pain intensity (SPID) using the categorical pain intensity scale
  • Time-interval weighted sum of pain relief and pain intensity difference (SPRID)
  • Perceptible pain relief
  • Meaningful pain relief
  • Rescue/supplemental medication use
  • Pain relief (PR)
  • Pain intensity (PI)
  • Subject Global Assessment of Study Drug
Not Provided
Not Provided
 
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy
A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended-Release Hydrocodone/Acetaminophen compared to 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 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pain
  • Drug: Hydrocodone/Acetaminophen Extended-Release
    1 tablet q 12 hours
    Other Names:
    • ABT-712
    • hydrocodone / acetaminophen extended release
  • Drug: Hydrocodone/Acetaminophen Extended Release
    2 tablets q 12 hours
    Other Names:
    • ABT-712
    • hydrocodone / acetaminophen extended release
  • Drug: Placebo
    2 tablets q 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: Arm 3: 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
150
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females ages 18 to 65
  • Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery
  • Meet specific pain intensity criteria on the morning after surgery
  • Willing to be confined for 4 days following surgery
  • If female, must be of non-child bearing potential or practicing birth control

Exclusion Criteria:

  • Is allergic to or has a serious reaction to hydrocodone, acetaminophen, lidocaine, propofol, morphine sulfate, oxycodone, and/or similar drugs
  • Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a history of certain gastrointestinal diseases that may narrow or slow down the gastrointestinal tract
  • Has specific active or uncontrolled seizure disorders
  • Has been diagnosed with certain cancers within the past 5 years
  • Has a history of certain psychiatric disorders or requires treatment with certain drugs for depression
  • Has specific clinically significant illnesses or laboratory abnormalities
  • Has received corticosteroid treatment or any investigational drug within a specific timeframe
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402792
M05-765
No
Andrea Best, DO, MPH, 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