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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis

Conditions
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Pain

Intervention / Treatment
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* Drug: Extended-Release Hydrocodone/Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrocodone/acetaminophen extended release<br> | Drug: Extended-Release Hydrocodone/Acetaminophen<br>* 2 tablets BID<br>* Other names: hydrocodone/acetaminophen extended release;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 tablets BID<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Osteoarthritis Index, SF36 | Osteoarthritis Index | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain associated with osteoarthritis