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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Analgesics; Hydrocodone; Oxycodone

Criteria

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