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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00404391
Recruitment Status : Completed
First Posted : November 28, 2006
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE November 26, 2006
First Posted Date  ICMJE November 28, 2006
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE October 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2006)
Time-interval-weighted sum of pain relief (TOTPAR) score for 0 to 12 hours following the first dose of study drug administration.
Change History Complete list of historical versions of study NCT00404391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
Time interval weighted sum of pain intensity difference (SPID)scores [ Time Frame: 12 hours ]
Sum of pain intensity difference
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2006)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Hydrocodone/Acetaminophen Extended Release
    1 tablet every 12 hours
    Other Name: ABT-712
  • Drug: Hydrocodone/Acetaminophen Extended Release
    2 tablets every 12 hours
    Other Name: ABT-712
  • Drug: Placebo
    2 tablets every 12 hours
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2006)
210
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2004
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00404391
Other Study ID Numbers  ICMJE M03-609
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Victor Jorden, MD, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rita Jain, MD Abbott
PRS Account Abbott
Verification Date January 2011

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