A Study of Pain Relief in Osteoarthritis
- Conditions
- Osteoarthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00298974
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 873
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - hydrocodone/acetaminophen extended release hydrocodone / acetaminophen extended release -
- Primary Outcome Measures
Name Time Method Pain Intensity 12 weeks Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (83)
Site Ref # / Investigator 393
🇺🇸Tucson, Arizona, United States
Site Ref # / Investigator 526
🇺🇸Anaheim, California, United States
Site Ref # / Investigator 721
🇺🇸Los Angeles, California, United States
Site Ref # / Investigator 715
🇺🇸Fall River, Massachusetts, United States
Site Ref # / Investigator 457
🇺🇸Pembroke Pines, Florida, United States
Site Ref # / Investigator 437
🇺🇸Marietta, Georgia, United States
Site Ref # / Investigator 2419
🇺🇸St. Louis, Missouri, United States
Site Ref # / Investigator 582
🇺🇸Columbus, Ohio, United States
Site Ref # / Investigator 558
🇺🇸Dallas, Texas, United States
Site Ref # / Investigator 388
🇺🇸Longwood, Florida, United States
Site Ref # / Investigator 357
🇺🇸Fair Oaks, California, United States
Site Ref # / Investigator 709
🇺🇸Littleton, Colorado, United States
Site Ref # / Investigator 453
🇺🇸Tempe, Arizona, United States
Site Ref # / Investigator 420
🇺🇸Ocala, Florida, United States
Site Ref # / Investigator 584
🇺🇸Tucson, Arizona, United States
Site Ref # / Investigator 580
🇺🇸Mobile, Alabama, United States
Site Ref # / Investigator 497
🇺🇸Clearwater, Florida, United States
Site Ref # / Investigator 2421
🇺🇸Sierra Vista, Arizona, United States
Site Ref # / Investigator 417
🇺🇸Daytona Beach, Florida, United States
Site Ref # / Investigator 481
🇺🇸St. Petersburg, Florida, United States
Site Ref # / Investigator 583
🇺🇸Wheat Ridge, Colorado, United States
Site Ref # / Investigator 434
🇺🇸Plantation, Florida, United States
Site Ref # / Investigator 474
🇺🇸Miami, Florida, United States
Site Ref # / Investigator 416
🇺🇸Cleveland, Ohio, United States
Site Ref # / Investigator 423
🇺🇸Birmingham, Alabama, United States
Site Ref # / Investigator 543
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 2582
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 508
🇺🇸Oklahoma City, Oklahoma, United States
Site Ref # / Investigator 581
🇺🇸Birmingham, Alabama, United States
Site Ref # / Investigator 459
🇺🇸Birmingham, Alabama, United States
Site Ref # / Investigator 479
🇺🇸Phoenix, Arizona, United States
Site Ref # / Investigator 439
🇺🇸San Diego, California, United States
Site Ref # / Investigator 521
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 724
🇺🇸Cincinnati, Ohio, United States
Site Ref # / Investigator 476
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 727
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 2420
🇺🇸San Antonio, Texas, United States
Site Ref # / Investigator 450
🇺🇸Salt Lake City, Utah, United States
Site Ref # / Investigator 411
🇺🇸Omaha, Nebraska, United States
Site Ref # / Investigator 2430
🇺🇸Portland, Oregon, United States
Site Ref # / Investigator 489
🇺🇸Plantation, Florida, United States
Site Ref # / Investigator 433
🇺🇸Ocala, Florida, United States
Site Ref # / Investigator 533
🇺🇸Buena Park, California, United States
Site Ref # / Investigator 366
🇺🇸Jupiter, Florida, United States
Site Ref # / Investigator 505
🇺🇸DeLand, Florida, United States
Site Ref # / Investigator 359
🇺🇸Oldsmar, Florida, United States
Site Ref # / Investigator 719
🇺🇸Port Orange, Florida, United States
Site Ref # / Investigator 2598
🇺🇸Meridian, Idaho, United States
Site Ref # / Investigator 458
🇺🇸West Palm Beach, Florida, United States
Site Ref # / Investigator 2594
🇺🇸Tampa, Florida, United States
Site Ref # / Investigator 550
🇺🇸Chicago, Illinois, United States
Site Ref # / Investigator 418
🇺🇸Pasadena, Maryland, United States
Site Ref # / Investigator 355
🇺🇸Louisville, Kentucky, United States
Site Ref # / Investigator 523
🇺🇸Newburgh, Indiana, United States
Site Ref # / Investigator 468
🇺🇸Owings Mills, Maryland, United States
Site Ref # / Investigator 527
🇺🇸West Yarmouth, Massachusetts, United States
Site Ref # / Investigator 560
🇺🇸Brockton, Massachusetts, United States
Site Ref # / Investigator 529
🇺🇸Biloxi, Mississippi, United States
Site Ref # / Investigator 522
🇺🇸Wellesley Hills, Massachusetts, United States
Site Ref # / Investigator 2544
🇺🇸Florissant, Missouri, United States
Site Ref # / Investigator 389
🇺🇸Mamaroneck, New York, United States
Site Ref # / Investigator 501
🇺🇸Roslyn, New York, United States
Site Ref # / Investigator 528
🇺🇸New York, New York, United States
Site Ref # / Investigator 525
🇺🇸Centerville, Ohio, United States
Site Ref # / Investigator 349
🇺🇸Winston-Salem, North Carolina, United States
Site Ref # / Investigator 452
🇺🇸Monroe, North Carolina, United States
Site Ref # / Investigator 723
🇺🇸Eugene, Oregon, United States
Site Ref # / Investigator 530
🇺🇸Zanesville, Ohio, United States
Site Ref # / Investigator 713
🇺🇸Mechanicsburg, Pennsylvania, United States
Site Ref # / Investigator 504
🇺🇸Milan, Tennessee, United States
Site Ref # / Investigator 486
🇺🇸West Reading, Pennsylvania, United States
Site Ref # / Investigator 466
🇺🇸Greenville, South Carolina, United States
Site Ref # / Investigator 493
🇺🇸Duncansville, Pennsylvania, United States
Site Ref # / Investigator 351
🇺🇸Cranston, Rhode Island, United States
Site Ref # / Investigator 425
🇺🇸Greer, South Carolina, United States
Site Ref # / Investigator 350
🇺🇸Austin, Texas, United States
Site Ref # / Investigator 454
🇺🇸Chesapeake, Virginia, United States
Site Ref # / Investigator 435
🇺🇸Virginia Beach, Virginia, United States
Site Ref # / Investigator 556
🇺🇸Virginia Beach, Virginia, United States
Site Ref # / Investigator 503
🇺🇸Virginia Beach, Virginia, United States
Site Ref # / Investigator 2599
🇺🇸Spokane, Washington, United States
Site Ref # / Investigator 410
🇺🇸New Orleans, Louisiana, United States
Site Ref # / Investigator 511
🇺🇸Evansville, Indiana, United States