A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00404222
First received: November 26, 2006
Last updated: July 22, 2011
Last verified: July 2011

November 26, 2006
July 22, 2011
November 2005
February 2006   (final data collection date for primary outcome measure)
  • The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Sum of Pain Intensity Difference using a 100mm Visual Analog Scale (VAS) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours following study drug administration.
Complete list of historical versions of study NCT00404222 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 ]
  • Time to first noticeable pain relief (i.e., onset of pain relief) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing meaningful pain relief after dosing [ 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)
  • Time to first noticeable pain relief (i.e., onset of pain relief)
  • Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline
  • Time to rescue medication
  • Proportion of subjects using rescue medication
  • Proportion of subjects experiencing meaningful pain relief after dosing
  • Mean pain relief and pain intensity at each scheduled pain evaluation and the subject global evaluation
Not Provided
Not Provided
 
A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy
A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) 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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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: Single Blind
Primary Purpose: Treatment
Pain
  • Drug: Hydrocodone/Acetaminophen Extended-Release
    2 tablets x 1
    Other Name: hydrocodone / acetaminophen extended release
  • Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
    1 tablet q 4 hours x 3
    Other Name: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
  • Drug: Placebo
    q 4 hours x 3
    Other Name: placebo
  • Experimental: hydrocodone / acetaminophen extended release
    Intervention: Drug: Hydrocodone/Acetaminophen Extended-Release
  • Active Comparator: Hydrocodone/Acetaminophen Immediate Release (Norco ®)
    Intervention: Drug: Hydrocodone/Acetaminophen Immediate Release (NORCO®)
  • 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
90
February 2006
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females ages 18 to 65
  • Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
  • Must meet specific pain intensity criteria on the morning after surgery
  • Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
  • Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
  • Has a history of or currently has any active seizure disorder
  • Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
  • Has been diagnosed with cancer within the past 3 years
  • Requires treatment with certain drugs for depression or psychiatric disorders
  • Has specific clinically significant illnesses or laboratory abnormalities
  • 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
Not Provided
 
NCT00404222
M05-772
No
Victor Jorden, MD, Abbott
Abbott
Not Provided
Study Director: Rita Jain, MD Abbott
Abbott
July 2011

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