Clinical trial NCT00298974: A Study of Pain Relief in Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis of the hip or knee
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-03-06
Enrollment: 873
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain intensity difference (PID) from baseline to each scheduled evaluation
timeFrame: 12 weeks
measure: Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score
timeFrame: 12 weeks
measure: SF-36v2 Health Status Survey
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Ref # / Investigator 423
state: Alabama
city: Birmingham
country: United States
facility: Site Ref # / Investigator 581
state: Alabama
city: Birmingham
country: United States
facility: Site Ref # / Investigator 459
state: Alabama
city: Mobile
country: United States
facility: Site Ref # / Investigator 580
state: Alabama
city: Phoenix
country: United States
facility: Site Ref # / Investigator 479
state: Arizona
city: Phoenix
country: United States
facility: Site Ref # / Investigator 543
state: Arizona
city: Phoenix
country: United States
facility: Site Ref # / Investigator 2582
state: Arizona
city: Sierra Vista
country: United States
facility: Site Ref # / Investigator 2421
state: Arizona
city: Tempe
country: United States
facility: Site Ref # / Investigator 453
state: Arizona
city: Tucson
country: United States
facility: Site Ref # / Investigator 584
state: Arizona
city: Tucson
country: United States
facility: Site Ref # / Investigator 393
state: Arizona
city: Anaheim
country: United States
facility: Site Ref # / Investigator 526
state: California
city: Buena Park
country: United States
facility: Site Ref # / Investigator 533
state: California
city: Fair Oaks
country: United States
facility: Site Ref # / Investigator 357
state: California
city: Los Angeles
country: United States
facility: Site Ref # / Investigator 721
state: California
city: San Diego
country: United States
facility: Site Ref # / Investigator 439
state: California
city: Littleton
country: United States
facility: Site Ref # / Investigator 709
state: Colorado
city: Wheat Ridge
country: United States
facility: Site Ref # / Investigator 583
state: Colorado
city: Clearwater
country: United States
facility: Site Ref # / Investigator 497
state: Florida
city: Daytona Beach
country: United States
facility: Site Ref # / Investigator 417
state: Florida
city: DeLand
country: United States
facility: Site Ref # / Investigator 505
state: Florida
city: Jupiter
country: United States
facility: Site Ref # / Investigator 366
state: Florida
city: Longwood
country: United States
facility: Site Ref # / Investigator 388
state: Florida
city: Miami
country: United States
facility: Site Ref # / Investigator 474
state: Florida
city: Ocala
country: United States
facility: Site Ref # / Investigator 433
state: Florida
city: Ocala
country: United States
facility: Site Ref # / Investigator 420
state: Florida
city: Oldsmar
country: United States
facility: Site Ref # / Investigator 359
state: Florida
city: Pembroke Pines
country: United States
facility: Site Ref # / Investigator 457
state: Florida
city: Plantation
country: United States
facility: Site Ref # / Investigator 434
state: Florida
city: Plantation
country: United States
facility: Site Ref # / Investigator 489
state: Florida
city: Port Orange
country: United States
facility: Site Ref # / Investigator 719
state: Florida
city: St. Petersburg
country: United States
facility: Site Ref # / Investigator 481
state: Florida
city: Tampa
country: United States
facility: Site Ref # / Investigator 2594
state: Florida
city: West Palm Beach
country: United States
facility: Site Ref # / Investigator 458
state: Florida
city: Marietta
country: United States
facility: Site Ref # / Investigator 437
state: Georgia
city: Meridian
country: United States
facility: Site Ref # / Investigator 2598
state: Idaho
city: Chicago
country: United States
facility: Site Ref # / Investigator 550
state: Illinois
city: Evansville
country: United States
facility: Site Ref # / Investigator 511
state: Indiana
city: Newburgh
country: United States
facility: Site Ref # / Investigator 523
state: Indiana
city: Louisville
country: United States
facility: Site Ref # / Investigator 355
state: Kentucky
city: New Orleans
country: United States
facility: Site Ref # / Investigator 410
state: Louisiana
city: Owings Mills
country: United States
facility: Site Ref # / Investigator 468
state: Maryland
city: Pasadena
country: United States
facility: Site Ref # / Investigator 418
state: Maryland
city: Brockton
country: United States
facility: Site Ref # / Investigator 560
state: Massachusetts
city: Fall River
country: United States
facility: Site Ref # / Investigator 715
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Site Ref # / Investigator 522
state: Massachusetts
city: West Yarmouth
country: United States
facility: Site Ref # / Investigator 527
state: Massachusetts
city: Biloxi
country: United States
facility: Site Ref # / Investigator 529
state: Mississippi
city: Florissant
country: United States
facility: Site Ref # / Investigator 2544
state: Missouri
city: St. Louis
country: United States
facility: Site Ref # / Investigator 2419
state: Missouri
city: Omaha
country: United States
facility: Site Ref # / Investigator 411
state: Nebraska
city: Mamaroneck
country: United States
facility: Site Ref # / Investigator 389
state: New York
city: New York
country: United States
facility: Site Ref # / Investigator 528
state: New York
city: Roslyn
country: United States
facility: Site Ref # / Investigator 501
state: New York
city: Monroe
country: United States
facility: Site Ref # / Investigator 452
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Ref # / Investigator 349
state: North Carolina
city: Centerville
country: United States
facility: Site Ref # / Investigator 525
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 724
state: Ohio
city: Cincinnati
country: United States
facility: Site Ref # / Investigator 521
state: Ohio
city: Cleveland
country: United States
facility: Site Ref # / Investigator 416
state: Ohio
city: Columbus
country: United States
facility: Site Ref # / Investigator 582
state: Ohio
city: Zanesville
country: United States
facility: Site Ref # / Investigator 530
state: Ohio
city: Oklahoma City
country: United States
facility: Site Ref # / Investigator 508
state: Oklahoma
city: Eugene
country: United States
facility: Site Ref # / Investigator 723
state: Oregon
city: Portland
country: United States
facility: Site Ref # / Investigator 2430
state: Oregon
city: Duncansville
country: United States
facility: Site Ref # / Investigator 493
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Site Ref # / Investigator 713
state: Pennsylvania
city: West Reading
country: United States
facility: Site Ref # / Investigator 486
state: Pennsylvania
city: Cranston
country: United States
facility: Site Ref # / Investigator 351
state: Rhode Island
city: Greenville
country: United States
facility: Site Ref # / Investigator 466
state: South Carolina
city: Greer
country: United States
facility: Site Ref # / Investigator 425
state: South Carolina
city: Milan
country: United States
facility: Site Ref # / Investigator 504
state: Tennessee
city: Austin
country: United States
facility: Site Ref # / Investigator 350
state: Texas
city: Dallas
country: United States
facility: Site Ref # / Investigator 558
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 727
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 2420
state: Texas
city: San Antonio
country: United States
facility: Site Ref # / Investigator 476
state: Texas
city: Salt Lake City
country: United States
facility: Site Ref # / Investigator 450
state: Utah
city: Chesapeake
country: United States
facility: Site Ref # / Investigator 454
state: Virginia
city: Virginia Beach
country: United States
facility: Site Ref # / Investigator 435
state: Virginia
city: Virginia Beach
country: United States
facility: Site Ref # / Investigator 556
state: Virginia
city: Virginia Beach
country: United States
facility: Site Ref # / Investigator 503
state: Virginia
city: Spokane
country: United States
facility: Site Ref # / Investigator 2599
state: Washington
Study officials:
affiliation: Abbott
name: Rita Jain, M.D.
role: STUDY_DIRECTOR
References: