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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
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Hydrocodone/Acetaminophen Extended-Release
Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: hydrocodone / acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended-Release
1 tablet q 12 hours
Other Names:
  • ABT-712
  • hydrocodone / acetaminophen extended release
Experimental: Arm 2: hydrocodone / acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets q 12 hours
Other Names:
  • ABT-712
  • hydrocodone / acetaminophen extended release
Placebo Comparator: Arm 3: Placebo Drug: Placebo
2 tablets q 12 hours
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402792

Locations
United States, Texas
Site Ref # / Investigator 2589
Austin, Texas, United States, 78705
Site Ref # / Investigator 2587
Houston, Texas, United States, 77081
Site Ref # / Investigator 2586
San Antonio, Texas, United States, 78229
Site Ref # / Investigator 2588
San Marcos, Texas, United States, 78666
United States, Utah
Site Ref # / Investigator 2585
Salt Lake City, Utah, United States, 84094
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

Responsible Party: Andrea Best, DO, MPH, Abbott
ClinicalTrials.gov Identifier: NCT00402792     History of Changes
Other Study ID Numbers: M05-765
Study First Received: November 20, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Acute pain following bunionectomy surgery

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013