A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following Bunionectomy - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00402792

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 III

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:

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

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 February 09, 2012