A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Detailed Description
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The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee

Conditions
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Osteoarthritis, Chronic Pain

Intervention / Treatment
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* Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 21 years of age or older Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential Negative pregnancy test if female of childbearing potential Subject is in general good health Subject required treatment of joint pain within the last 90 days Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee Exclusion Criteria: Subject has a documented history of allergic reaction or intolerance to morphine or other opioids Subject is pregnant or breast-feeding Subject is receiving systemic chemotherapy Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence Subject has history of major depressive disorder not controlled with medication Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD) Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis

Ages Eligible for Study
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Minimum Age: 21 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: ALO-01<br>Up to 80 mg twice a day (bid) | Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)<br>* capsules, up to 80 mg bid<br>* Other names: Embeda;|
| Placebo Comparator: Placebo<br>Twice a day (bid) | Drug: Placebo<br>* capsules, bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days) | Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain. | randomization to 12 weeks following randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip, knee, pain, osteoarthritis, OA, Kadian, Alpharma, naltrexone, Opioid, morphine, Embeda, ALO-01