A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis - 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 with placebo over a 5-week dosing period in patients with osteoarthritis.

Condition	Intervention	Phase
Pain	Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR)	Phase II

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Acetaminophen Hydrocodone Hydrocodone bitartrate Vicodin

U.S. FDA Resources

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

Official Title:	A Randomized, Multi-Center, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

Further study details as provided by Abbott:

Primary Outcome Measures:

Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").

Secondary Outcome Measures:

WOMAC Osteoarthritis Index
MOS Sleep Scale
Pain Intensity difference as assessed by the Subject’s Assessment of Arthritis Pain Intensity by VAS (at each scheduled assessment other than final)
Subject’s Global Assessment of Study Drug
Subject’s and Physician’s Global Assessment of Arthritis Status
Time-interval weighted measure of pain intensity difference from baseline (area under the curve) divided by the maximum benefit possible for an individual subject
Treatment responders
SF-36v2TM Health Status Survey (Acute)

Estimated Enrollment:	120
Study Start Date:	August 2004
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females ages 21 to 75
Has osteoarthritis of the hip or knee
Requires therapeutic doses of medications for osteoarthritis
If female, must be of non-childbearing potential or practicing birth control
Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
Has certain medical conditions which may interfere with pain assessments
Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
Has had certain infections, injuries or illnesses within the last month
Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
Cannot discontinue pain medications, even for a short time, prior to the study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404183

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Rita Jain, MD	Abbott

More Information

Study ID Numbers:	M03-643
First Received:	November 26, 2006
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00404183
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Pain associated with osteoarthritis

Study placed in the following topic categories:

Osteoarthritis

Joint Diseases

Pain

Rheumatic Diseases

Naphazoline

Oxymetazoline

Musculoskeletal Diseases

Phenylephrine

Guaifenesin

Arthritis

Hydrocodone

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:	NCT00404183