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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Time interval weighted sum of pain intensity difference (SPID)scores [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    Sum of pain intensity difference


Enrollment: 210
Study Start Date: October 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (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 every 12 hours
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release
Experimental: Arm 2: hydrocodone/acetaminophen extended release Drug: Hydrocodone/Acetaminophen Extended Release
2 tablets every 12 hours
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release
Placebo Comparator: placebo Drug: Placebo
2 tablets every 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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404391

Locations
United States, Maryland
Site Ref # / Investigator 4993
Owing Mills, Maryland, United States, 21117
United States, Texas
Site Ref # / Investigator 4994
Austin, Texas, United States, 78705
Site Ref # / Investigator 4992
San Marcos, Texas, United States, 78666
United States, Utah
Site Ref # / Investigator 4995
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, MD Abbott
  More Information

No publications provided

Responsible Party: Victor Jorden, MD, Abbott
ClinicalTrials.gov Identifier: NCT00404391     History of Changes
Other Study ID Numbers: M03-609
Study First Received: November 26, 2006
Last Updated: January 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Moderate to severe pain following bunionectomy surgery

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
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 July 29, 2014