A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

Abbott

Status and phase

Completed

Phase 2

Conditions

Pain

Treatments

Drug: Extended-Release Hydrocodone/Acetaminophen

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00404183

M03-643

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.

Enrollment

120 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females ages 21 to 75
Has osteoarthritis of the hip or knee
Requires therapeutic doses of medications for osteoarthritis
If female, must be of non-childbearing potential or practicing birth control
Has sufficient pain to justify the use of round-the-clock opioids

Exclusion criteria

Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
Has certain medical conditions which may interfere with pain assessments
Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
Has had certain infections, injuries or illnesses within the last month
Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
Cannot discontinue pain medications, even for a short time, prior to the study start