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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Extended-Release Hydrocodone/Acetaminophen; Drug: Placebo

• Registration Number: NCT00404183
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-03
• Study First Submitted: 2006-11-26
• Study First Submitted QC: 2006-11-26
• Study First Posted: 2006-11-28
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-14
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydrocodone/acetaminophen extended release	Extended-Release Hydrocodone/Acetaminophen	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").	4 weeks	Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)

Secondary Outcome Measures

Name	Time	Method
WOMAC Osteoarthritis Index, SF36	4 weeks	Osteoarthritis Index