A Study of Pain Relief in Osteoarthritis

Abbott

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: hydrocodone / acetaminophen extended release; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298974

M04-697

Details and patient eligibility

About

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.

Enrollment: 873 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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873 participants in 2 patient groups, including a placebo group

hydrocodone/acetaminophen extended release

Experimental group

Treatment:

Drug: hydrocodone / acetaminophen extended release

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo