A Study of Pain Relief in Osteoarthritis

January 24, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

873

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
2 tablets twice daily
Experimental: hydrocodone/acetaminophen extended release
Drug: hydrocodone / acetaminophen extended release
2 tablets twice daily
Other Names:
  • ABT-712

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 12 weeks
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity difference (PID) from baseline to each scheduled evaluation
Time Frame: 12 weeks
12 weeks
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score
Time Frame: 12 weeks
12 weeks
SF-36v2 Health Status Survey
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Rita Jain, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 2, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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