A Study of Pain Relief in Osteoarthritis

NCT00298974 | Completed Phase 3

• 1 other identifier: M04-697
• Study Type: interventional
• Target: 873
• Locations: 1 country
• Sites: 83

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis of the hip or knee

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)

  12 weeks

Secondary Outcomes (3)

• Pain intensity difference (PID) from baseline to each scheduled evaluation

  12 weeks

• Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score

  12 weeks

• SF-36v2 Health Status Survey

  12 weeks

Study Arms (2)

hydrocodone/acetaminophen extended release

EXPERIMENTAL

Drug: hydrocodone / acetaminophen extended release

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

hydrocodone / acetaminophen extended release DRUG

2 tablets twice daily

Also known as: ABT-712

hydrocodone/acetaminophen extended release

Placebo DRUG

2 tablets twice daily

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (83)

Site Ref # / Investigator 423

Birmingham, Alabama, 35235, United States

Location

Site Ref # / Investigator 581

Birmingham, Alabama, 35235, United States

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Site Ref # / Investigator 459

Birmingham, Alabama, 35244, United States

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Site Ref # / Investigator 580

Mobile, Alabama, 36608, United States

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Site Ref # / Investigator 479

Phoenix, Arizona, 85012, United States

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Site Ref # / Investigator 543

Phoenix, Arizona, 85014, United States

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Site Ref # / Investigator 2582

Phoenix, Arizona, 85023, United States

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Site Ref # / Investigator 2421

Sierra Vista, Arizona, 85635, United States

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Site Ref # / Investigator 453

Tempe, Arizona, 85282, United States

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Site Ref # / Investigator 584

Tucson, Arizona, 85712, United States

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Site Ref # / Investigator 393

Tucson, Arizona, 85741, United States

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Site Ref # / Investigator 526

Anaheim, California, 92801, United States

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Site Ref # / Investigator 533

Buena Park, California, 90620, United States

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Site Ref # / Investigator 357

Fair Oaks, California, 95628, United States

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Site Ref # / Investigator 721

Los Angeles, California, 90095-1670, United States

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Site Ref # / Investigator 439

San Diego, California, 92108, United States

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Site Ref # / Investigator 709

Littleton, Colorado, 80120, United States

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Site Ref # / Investigator 583

Wheat Ridge, Colorado, 80033, United States

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Site Ref # / Investigator 497

Clearwater, Florida, 33756, United States

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Site Ref # / Investigator 417

Daytona Beach, Florida, 32117, United States

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Site Ref # / Investigator 505

DeLand, Florida, 32720, United States

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Site Ref # / Investigator 366

Jupiter, Florida, 33458-7200, United States

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Site Ref # / Investigator 388

Longwood, Florida, 32779, United States

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Site Ref # / Investigator 474

Miami, Florida, 33156, United States

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Site Ref # / Investigator 433

Ocala, Florida, 34471, United States

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Site Ref # / Investigator 420

Ocala, Florida, 34474, United States

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Site Ref # / Investigator 359

Oldsmar, Florida, 34677, United States

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Site Ref # / Investigator 457

Pembroke Pines, Florida, 33024, United States

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Site Ref # / Investigator 434

Plantation, Florida, 33324, United States

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Site Ref # / Investigator 489

Plantation, Florida, 33324, United States

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Site Ref # / Investigator 719

Port Orange, Florida, 32127, United States

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Site Ref # / Investigator 481

St. Petersburg, Florida, 33703, United States

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Site Ref # / Investigator 2594

Tampa, Florida, 33613, United States

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Site Ref # / Investigator 458

West Palm Beach, Florida, 33409-3509, United States

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Site Ref # / Investigator 437

Marietta, Georgia, 30066, United States

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Site Ref # / Investigator 2598

Meridian, Idaho, 83642, United States

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Site Ref # / Investigator 550

Chicago, Illinois, 60611, United States

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Site Ref # / Investigator 511

Evansville, Indiana, 47714, United States

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Site Ref # / Investigator 523

Newburgh, Indiana, 47630, United States

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Site Ref # / Investigator 355

Louisville, Kentucky, 40213, United States

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Site Ref # / Investigator 410

New Orleans, Louisiana, 70115, United States

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Site Ref # / Investigator 468

Owings Mills, Maryland, 21117, United States

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Site Ref # / Investigator 418

Pasadena, Maryland, 21122, United States

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Site Ref # / Investigator 560

Brockton, Massachusetts, 02301, United States

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Site Ref # / Investigator 715

Fall River, Massachusetts, 02720, United States

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Site Ref # / Investigator 522

Wellesley Hills, Massachusetts, 02481-2106, United States

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Site Ref # / Investigator 527

West Yarmouth, Massachusetts, 02673, United States

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Site Ref # / Investigator 529

Biloxi, Mississippi, 39531, United States

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Site Ref # / Investigator 2544

Florissant, Missouri, 63031, United States

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Site Ref # / Investigator 2419

St Louis, Missouri, 63141, United States

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Site Ref # / Investigator 411

Omaha, Nebraska, 68134, United States

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Site Ref # / Investigator 389

Mamaroneck, New York, 10543, United States

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Site Ref # / Investigator 528

New York, New York, 10022, United States

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Site Ref # / Investigator 501

Roslyn, New York, 11576, United States

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Site Ref # / Investigator 452

Monroe, North Carolina, 28112, United States

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Site Ref # / Investigator 349

Winston-Salem, North Carolina, 27103, United States

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Site Ref # / Investigator 525

Centerville, Ohio, 45459, United States

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Site Ref # / Investigator 724

Cincinnati, Ohio, 45236, United States

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Site Ref # / Investigator 521

Cincinnati, Ohio, 45242, United States

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Site Ref # / Investigator 416

Cleveland, Ohio, 44122, United States

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Site Ref # / Investigator 582

Columbus, Ohio, 43235, United States

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Site Ref # / Investigator 530

Zanesville, Ohio, 43701, United States

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Site Ref # / Investigator 508

Oklahoma City, Oklahoma, 73103, United States

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Site Ref # / Investigator 723

Eugene, Oregon, 97404, United States

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Site Ref # / Investigator 2430

Portland, Oregon, 97201, United States

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Site Ref # / Investigator 493

Duncansville, Pennsylvania, 16635, United States

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Site Ref # / Investigator 713

Mechanicsburg, Pennsylvania, 17055, United States

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Site Ref # / Investigator 486

West Reading, Pennsylvania, 19611-1124, United States

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Site Ref # / Investigator 351

Cranston, Rhode Island, 02920, United States

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Site Ref # / Investigator 466

Greenville, South Carolina, 29601, United States

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Site Ref # / Investigator 425

Greer, South Carolina, 29651, United States

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Site Ref # / Investigator 504

Milan, Tennessee, 38358, United States

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Site Ref # / Investigator 350

Austin, Texas, 78705, United States

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Site Ref # / Investigator 558

Dallas, Texas, 75230, United States

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Site Ref # / Investigator 727

San Antonio, Texas, 78209, United States

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Site Ref # / Investigator 2420

San Antonio, Texas, 78229, United States

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Site Ref # / Investigator 476

San Antonio, Texas, 78229, United States

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Site Ref # / Investigator 450

Salt Lake City, Utah, 84102, United States

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Site Ref # / Investigator 454

Chesapeake, Virginia, 23320, United States

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Site Ref # / Investigator 435

Virginia Beach, Virginia, 23451, United States

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Site Ref # / Investigator 556

Virginia Beach, Virginia, 23454, United States

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Site Ref # / Investigator 503

Virginia Beach, Virginia, 23455, United States

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Site Ref # / Investigator 2599

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip

Interventions

Hydrocodone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rita Jain, M.D.

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 25, 2011

Record last verified: 2011-01

Locations

US (83)