Status:
COMPLETED
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Lead Sponsor:
Pfizer
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT00415597
Start Date
December 1 2006
End Date
March 1 2008
Last Update
September 20 2013
Active Locations (58)
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1
Michael Gibson, MD
Birmingham, Alabama, United States, 35244
2
Steven Siwek, MD
Phoenix, Arizona, United States, 85027
3
Michael Loes, MD
Phoenix, Arizona, United States, 85032
4
Allan Soo, MD
Tempe, Arizona, United States, 85282