A Study of Pain Relief in Osteoarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID: NCT00298974
Run by: Abbott
People needed: 873
Starts: 2006-02-01
Expected to finish: 2007-05-01
Last updated by the study team: 2011-01-25

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Site Ref # / Investigator 581 — Birmingham, Alabama, United States
Site Ref # / Investigator 459 — Birmingham, Alabama, United States
Site Ref # / Investigator 580 — Mobile, Alabama, United States
Site Ref # / Investigator 479 — Phoenix, Arizona, United States
Site Ref # / Investigator 543 — Phoenix, Arizona, United States
Site Ref # / Investigator 2582 — Phoenix, Arizona, United States
Site Ref # / Investigator 2421 — Sierra Vista, Arizona, United States
Site Ref # / Investigator 453 — Tempe, Arizona, United States
Site Ref # / Investigator 584 — Tucson, Arizona, United States
Site Ref # / Investigator 393 — Tucson, Arizona, United States
Site Ref # / Investigator 526 — Anaheim, California, United States
Site Ref # / Investigator 533 — Buena Park, California, United States
Site Ref # / Investigator 357 — Fair Oaks, California, United States
Site Ref # / Investigator 721 — Los Angeles, California, United States
Site Ref # / Investigator 439 — San Diego, California, United States
Site Ref # / Investigator 709 — Littleton, Colorado, United States
Site Ref # / Investigator 583 — Wheat Ridge, Colorado, United States
Site Ref # / Investigator 497 — Clearwater, Florida, United States
Site Ref # / Investigator 417 — Daytona Beach, Florida, United States
Site Ref # / Investigator 505 — DeLand, Florida, United States
Site Ref # / Investigator 366 — Jupiter, Florida, United States
Site Ref # / Investigator 388 — Longwood, Florida, United States
Site Ref # / Investigator 474 — Miami, Florida, United States
Site Ref # / Investigator 433 — Ocala, Florida, United States
Site Ref # / Investigator 423 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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