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.

First Received: November 26, 2006 Last Updated: April 21, 2009 History of Changes

Sponsored by:	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 (Vicodin® CR)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

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 relief (TOTPAR) score for 0 to 12 hours following the first dose of study drug administration.

Secondary Outcome Measures:

Time-interval-weighted sum of pain intensity difference (SPID) scores
Time interval weighted sum of pain relief and pain intensity difference (SPRID)
Time to first noticeable pain relief (i.e., onset of pain)
Time to first meaningful pain relief (i.e, 50% reduction in pain from baseline)
Time to rescue medication
Proportion of subjects experiencing meaningful pain relief after dosing
Mean pain relief and pain intensity at each scheduled pain evaluation
Subject Global Evaluation

Estimated Enrollment:	210
Study Start Date:	October 2003
Estimated Study Completion Date:	March 2004

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

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Rita Jain, MD

Abbott

More Information

No publications provided

Study ID Numbers:	M03-609
Study First Received:	November 26, 2006
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00404391 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Moderate to severe 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 September 03, 2009