A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00404391

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 II

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:

Drug Information available for: Acetaminophen CT 2584 Hydrocodone Hydrocodone bitartrate Hycodan

U.S. FDA Resources

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

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 February 09, 2012