A Study of Pain Relief in Osteoarthritis - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00298974

Purpose

The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.

Condition	Intervention	Phase
Osteoarthritis	Drug: Vicodin CR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Vicodin

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

The mean absolute pain intensity difference from baseline to each subject's Week 12 evaluation

Secondary Outcome Measures:

Pain intensity difference from baseline to each scheduled evaluation
Proportion of treatment responders
Global assessments of study drug and arthritis status
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score and 3 subscales
SF-36v2 Health Status Survey

Estimated Enrollment:	800
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females ages 21 to 80
If female, must be of non-child bearing potential or practicing birth control
Has osteoarthritis of the hip or knee
Requires therapeutic doses of medication for osteoarthritis pain
Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Cannot discontinue pain medications, even for the short time prior to the study start
Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
Has a history of malnutrition or starvation
Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
Pregnant or breastfeeding females
Is incapacitated, bedridden or confined to a wheelchair
Has initiated any new therapy or medication for OA within 1 month of screening
Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
Has other conditions that may cause pain, such as rheumatoid arthritis or gout

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298974

Hide Study Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35244

Mobile, Alabama, United States, 36608

Birmingham, Alabama, United States, 35235
United States, Arizona

Phoenix, Arizona, United States, 85012

Sierra Vista, Arizona, United States, 85635

Pheonix, Arizona, United States, 85023

Tucson, Arizona, United States, 85712

Tempe, Arizona, United States, 85282

Phoenix, Arizona, United States, 85020

Tucson, Arizona, United States, 85741

Pheonix, Arizona, United States, 85014
United States, California

San Diego, California, United States, 92108

Fair Oaks, California, United States, 95628

Buena Park, California, United States, 90620

Los Angeles, California, United States, 90095-1670

Anaheim, California, United States, 92801
United States, Colorado

Wheatridge, Colorado, United States, 80033

Littleton, Colorado, United States, 80120
United States, Florida

Pembroke Pines, Florida, United States, 33024

Plantation, Florida, United States, 33324

Clearwater, Florida, United States, 33761

Ocala, Florida, United States, 34474

Miami, Florida, United States, 33156

Port Orange, Florida, United States, 32127

Ocala, Florida, United States, 34471

DeLand, Florida, United States, 32720

St. Petersburg, Florida, United States, 33703

Jupiter, Florida, United States, 33458-7200

Longwood, Florida, United States, 32779

Ormond Beach, Florida, United States, 32174

West Palm Beach, Florida, United States, 33409

Oldsmar, Florida, United States, 34677

Largo, Florida, United States, 33770

Brandon, Florida, United States, 33511
United States, Georgia

Marietta, Georgia, United States, 30066
United States, Idaho

Meridian, Idaho, United States, 83642
United States, Illinois

Chicago, Illinois, United States, 60611
United States, Indiana

Evansville, Indiana, United States, 47714

Newburgh, Indiana, United States, 47630
United States, Kentucky

Louisville, Kentucky, United States, 40213
United States, Louisiana

New Orleans, Louisiana, United States, 70115
United States, Maryland

Pasadena, Maryland, United States, 21122

Owings Mills, Maryland, United States, 21117
United States, Massachusetts

Fall River, Massachusetts, United States, 02720

Wellesley Hills, Massachusetts, United States, 02481

West Yarmouth, Massachusetts, United States, 02673

Brockton, Massachusetts, United States, 02301
United States, Michigan

Kalamazoo, Michigan, United States, 49009
United States, Mississippi

Biloxi, Mississippi, United States, 39531
United States, Missouri

St. Louis, Missouri, United States, 63141

Florissant, Missouri, United States, 63031
United States, Nebraska

Omaha, Nebraska, United States, 68134
United States, New York

Mamaroneck, New York, United States, 10543

Roslyn, New York, United States, 11576

New York, New York, United States, 10022
United States, North Carolina

Monroe, North Carolina, United States, 28112

Winston-Salem, North Carolina, United States, 27103
United States, Ohio

Zanesville, Ohio, United States, 43701

Cleveland, Ohio, United States, 44122

Cincinnati, Ohio, United States, 45236

Cincinnati, Ohio, United States, 45242

Columbus, Ohio, United States, 43235

Centerville, Ohio, United States, 45459
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73139
United States, Oregon

Portland, Oregon, United States, 97239

Eugene, Oregon, United States, 97404

Portland, Oregon, United States, 97201
United States, Pennsylvania

West Reading, Pennsylvania, United States, 19611

Mechanicsburg, Pennsylvania, United States, 17055

Duncansville, Pennsylvania, United States, 16635
United States, Rhode Island

Cranston, Rhode Island, United States, 02920
United States, South Carolina

Greenville, South Carolina, United States, 29601

Greer, South Carolina, United States, 29651
United States, Tennessee

Milan, Tennessee, United States, 38358
United States, Texas

San Antonio, Texas, United States, 78209

Austin, Texas, United States, 78705

San Antonio, Texas, United States, 78229

Richardson, Texas, United States, 75080
United States, Utah

Salt Lake City, Utah, United States, 84102
United States, Virginia

Virginia Beach, Virginia, United States, 23454

Virginia Beach, Virginia, United States, 23451

Virginia Beach, Virginia, United States, 23455
United States, Washington

Spokane, Washington, United States, 99204

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Rita Jain, M.D.

Abbott

More Information

No publications provided

Study ID Numbers:	M04-697
Study First Received:	March 2, 2006
Last Updated:	October 24, 2007
ClinicalTrials.gov Identifier:	NCT00298974 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Osteoarthritis of the hip or knee

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2009