A Study of Pain Relief in Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: hydrocodone / acetaminophen extended release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: hydrocodone / acetaminophen extended release<br>* 2 tablets twice daily<br>* Other names: ABT-712;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity difference (PID) from baseline to each scheduled evaluation |  | 12 weeks | 
| Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score |  | 12 weeks | 
| SF-36v2 Health Status Survey |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis of the hip or knee