A Study of Pain Relief in Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00298974
First received: March 2, 2006
Last updated: January 24, 2011
Last verified: January 2011
  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: hydrocodone / acetaminophen extended release
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)


Secondary Outcome Measures:
  • Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • SF-36v2 Health Status Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 873
Study Start Date: February 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydrocodone/acetaminophen extended release Drug: hydrocodone / acetaminophen extended release
2 tablets twice daily
Other Name: ABT-712
Placebo Comparator: Placebo Drug: Placebo
2 tablets twice daily
Other Name: Placebo

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Site Ref # / Investigator 581
Birmingham, Alabama, United States, 35235
Site Ref # / Investigator 423
Birmingham, Alabama, United States, 35235
Site Ref # / Investigator 459
Birmingham, Alabama, United States, 35244
Site Ref # / Investigator 580
Mobile, Alabama, United States, 36608
United States, Arizona
Site Ref # / Investigator 2582
Phoenix, Arizona, United States, 85023
Site Ref # / Investigator 479
Phoenix, Arizona, United States, 85012
Site Ref # / Investigator 543
Phoenix, Arizona, United States, 85014
Site Ref # / Investigator 2421
Sierra Vista, Arizona, United States, 85635
Site Ref # / Investigator 453
Tempe, Arizona, United States, 85282
Site Ref # / Investigator 584
Tucson, Arizona, United States, 85712
Site Ref # / Investigator 393
Tucson, Arizona, United States, 85741
United States, California
Site Ref # / Investigator 526
Anaheim, California, United States, 92801
Site Ref # / Investigator 533
Buena Park, California, United States, 90620
Site Ref # / Investigator 357
Fair Oaks, California, United States, 95628
Site Ref # / Investigator 721
Los Angeles, California, United States, 90095-1670
Site Ref # / Investigator 439
San Diego, California, United States, 92108
United States, Colorado
Site Ref # / Investigator 709
Littleton, Colorado, United States, 80120
Site Ref # / Investigator 583
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Site Ref # / Investigator 497
Clearwater, Florida, United States, 33756
Site Ref # / Investigator 417
Daytona Beach, Florida, United States, 32117
Site Ref # / Investigator 505
DeLand, Florida, United States, 32720
Site Ref # / Investigator 366
Jupiter, Florida, United States, 33458-7200
Site Ref # / Investigator 388
Longwood, Florida, United States, 32779
Site Ref # / Investigator 474
Miami, Florida, United States, 33156
Site Ref # / Investigator 420
Ocala, Florida, United States, 34474
Site Ref # / Investigator 433
Ocala, Florida, United States, 34471
Site Ref # / Investigator 359
Oldsmar, Florida, United States, 34677
Site Ref # / Investigator 457
Pembroke Pines, Florida, United States, 33024
Site Ref # / Investigator 434
Plantation, Florida, United States, 33324
Site Ref # / Investigator 489
Plantation, Florida, United States, 33324
Site Ref # / Investigator 719
Port Orange, Florida, United States, 32127
Site Ref # / Investigator 481
St. Petersburg, Florida, United States, 33703
Site Ref # / Investigator 2594
Tampa, Florida, United States, 33613
Site Ref # / Investigator 458
West Palm Beach, Florida, United States, 33409-3509
United States, Georgia
Site Ref # / Investigator 437
Marietta, Georgia, United States, 30066
United States, Idaho
Site Ref # / Investigator 2598
Meridian, Idaho, United States, 83642
United States, Illinois
Site Ref # / Investigator 550
Chicago, Illinois, United States, 60611
United States, Indiana
Site Ref # / Investigator 511
Evansville, Indiana, United States, 47714
Site Ref # / Investigator 523
Newburgh, Indiana, United States, 47630
United States, Kentucky
Site Ref # / Investigator 355
Louisville, Kentucky, United States, 40213
United States, Louisiana
Site Ref # / Investigator 410
New Orleans, Louisiana, United States, 70115
United States, Maryland
Site Ref # / Investigator 468
Owings Mills, Maryland, United States, 21117
Site Ref # / Investigator 418
Pasadena, Maryland, United States, 21122
United States, Massachusetts
Site Ref # / Investigator 560
Brockton, Massachusetts, United States, 02301
Site Ref # / Investigator 715
Fall River, Massachusetts, United States, 02720
Site Ref # / Investigator 522
Wellesley Hills, Massachusetts, United States, 02481-2106
Site Ref # / Investigator 527
West Yarmouth, Massachusetts, United States, 02673
United States, Mississippi
Site Ref # / Investigator 529
Biloxi, Mississippi, United States, 39531
United States, Missouri
Site Ref # / Investigator 2544
Florissant, Missouri, United States, 63031
Site Ref # / Investigator 2419
St. Louis, Missouri, United States, 63141
United States, Nebraska
Site Ref # / Investigator 411
Omaha, Nebraska, United States, 68134
United States, New York
Site Ref # / Investigator 389
Mamaroneck, New York, United States, 10543
Site Ref # / Investigator 528
New York, New York, United States, 10022
Site Ref # / Investigator 501
Roslyn, New York, United States, 11576
United States, North Carolina
Site Ref # / Investigator 452
Monroe, North Carolina, United States, 28112
Site Ref # / Investigator 349
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Site Ref # / Investigator 525
Centerville, Ohio, United States, 45459
Site Ref # / Investigator 724
Cincinnati, Ohio, United States, 45236
Site Ref # / Investigator 521
Cincinnati, Ohio, United States, 45242
Site Ref # / Investigator 416
Cleveland, Ohio, United States, 44122
Site Ref # / Investigator 582
Columbus, Ohio, United States, 43235
Site Ref # / Investigator 530
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Site Ref # / Investigator 508
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Site Ref # / Investigator 723
Eugene, Oregon, United States, 97404
Site Ref # / Investigator 2430
Portland, Oregon, United States, 97201
United States, Pennsylvania
Site Ref # / Investigator 493
Duncansville, Pennsylvania, United States, 16635
Site Ref # / Investigator 713
Mechanicsburg, Pennsylvania, United States, 17055
Site Ref # / Investigator 486
West Reading, Pennsylvania, United States, 19611-1124
United States, Rhode Island
Site Ref # / Investigator 351
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Site Ref # / Investigator 466
Greenville, South Carolina, United States, 29601
Site Ref # / Investigator 425
Greer, South Carolina, United States, 29651
United States, Tennessee
Site Ref # / Investigator 504
Milan, Tennessee, United States, 38358
United States, Texas
Site Ref # / Investigator 350
Austin, Texas, United States, 78705
Site Ref # / Investigator 558
Dallas, Texas, United States, 75230
Site Ref # / Investigator 727
San Antonio, Texas, United States, 78209
Site Ref # / Investigator 476
San Antonio, Texas, United States, 78229
Site Ref # / Investigator 2420
San Antonio, Texas, United States, 78229
United States, Utah
Site Ref # / Investigator 450
Salt Lake City, Utah, United States, 84102
United States, Virginia
Site Ref # / Investigator 454
Chesapeake, Virginia, United States, 23320
Site Ref # / Investigator 503
Virginia Beach, Virginia, United States, 23455
Site Ref # / Investigator 556
Virginia Beach, Virginia, United States, 23454
Site Ref # / Investigator 435
Virginia Beach, Virginia, United States, 23451
United States, Washington
Site Ref # / Investigator 2599
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Abbott
Investigators
Study Director: Rita Jain, M.D. Abbott
  More Information

No publications provided

Responsible Party: Earle Lockhart,MD, Abbott
ClinicalTrials.gov Identifier: NCT00298974     History of Changes
Other Study ID Numbers: M04-697
Study First Received: March 2, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Osteoarthritis of the hip or knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014