Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Study Overview
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Brief Summary
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Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

Official Title
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A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Conditions
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Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject 18-70 years of age Subject agrees to refrain from taking any opioid medications other than study medication during study period. History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline Exclusion Criteria: Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated. Subject is pregnant or breast-feeding. Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin). Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit. Subject has a Body Mass Index (BMI)>45kg/m2.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALO-01<br>Doses given once or twice daily | Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)<br>* capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily<br>* Other names: Embeda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product). | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. | 12 weeks | 
| Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, joint pain, back pain, diabetic peripheral neuropathy, post herpetic neuralgia, ALO-01, Embeda, Chronic Non-Malignant Pain