A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy - Full Text View

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 and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, 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) Drug: Immediate Release Hydrocodone/Acetaminophen (NORCO® )	Phase II

Drug Information available for:

Acetaminophen Hydrocodone Hydrocodone bitartrate Vicodin

U.S. FDA Resources

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

Official Title:	A Randomized, Multicenter, Single-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following Bunionectomy

Further study details as provided by Abbott:

Primary Outcome Measures:

The primary efficacy variable is the time-interval weighted sum of pain intensity difference (SPID) using the visual analog scale (VAS) for the 0 to 12 hours 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)
Time to first noticeable pain relief (i.e., onset of pain relief)
Time to first meaningful pain relief (i.e. 50% reduction in pain from baseline
Time to rescue medication
Proportion of subjects using rescue medication
Proportion of subjects experiencing meaningful pain relief after dosing
Mean pain relief and pain intensity at each scheduled pain evaluation and the subject global evaluation

Estimated Enrollment:	90
Study Start Date:	November 2005

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
Scheduled to undergo primary, unilateral, first metatarsal osteotomy (bunionectomy)
Must meet specific pain intensity criteria on the morning after surgery
Willing to remain at the study center 2 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, hydromorphone, oxycodone, acetaminophen, ketorolac, lidocaine, bupivacaine, or mepivacaine
Is allergic to or has a serious reaction to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
Has a history of or currently has any active seizure disorder
Has a history of or any disease causing severe gastrointestinal narrowing or slowing down the gastrointestinal tract
Has been diagnosed with cancer within the past 3 years
Requires treatment with certain drugs for depression or psychiatric disorders
Has specific clinically significant illnesses or laboratory abnormalities
Received corticosteroid treatment or any investigational drug within a specific timeframe.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404222

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Rita Jain, MD	Abbott

More Information

Study ID Numbers:	M05-772
First Received:	November 26, 2006
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00404222
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Acute Pain following Bunionectomy

Study placed in the following topic categories:

Naphazoline

Oxymetazoline

Guaifenesin

Phenylephrine

Hydrocodone

Pain

Phenylpropanolamine

Acetaminophen

Additional relevant MeSH terms:

Respiratory System Agents

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Analgesics

Peripheral Nervous System Agents

Antitussive Agents

Central Nervous System Agents

Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00404222