Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain (NCT00415597) | Clinical Trial Compass
CompletedPhase 3
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
United States467 participantsStarted 2006-12
Plain-language summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.