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

Sponsored by:	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: Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Surgery

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.

Secondary Outcome Measures:

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)
Perceptible pain relief
Meaningful pain relief
Rescue/supplemental medication use
Pain relief (PR)
Pain intensity (PI)
Subject Global Assessment of Study Drug

Estimated Enrollment:	150
Study Start Date:	December 2006

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, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Rita Jain, MD

Abbott

More Information

No publications provided

Study ID Numbers:	M05-765
Study First Received:	November 20, 2006
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00402792 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Acute pain following bunionectomy surgery

Study placed in the following topic categories:

Oxycodone
Central Nervous System Depressants
Pain
Narcotics
Naphazoline
Analgesics, Non-Narcotic
Guaifenesin

Hydrocodone
Analgesics
Peripheral Nervous System Agents
Phenylpropanolamine
Acetaminophen
Analgesics, Opioid

Additional relevant MeSH terms:

Respiratory System Agents
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Hydrocodone
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Acetaminophen
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009