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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
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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
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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013