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

Completed · Phase 3

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT00415597

Run by

Pfizer

People needed

467

Starts

2006-12-01

Expected to finish

2008-03-01

Last updated by the study team

2013-09-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Steven Siwek, MD — Phoenix, Arizona, United States
• Michael Loes, MD — Phoenix, Arizona, United States
• Allan Soo, MD — Tempe, Arizona, United States
• Leah Schmidt, DO — Tucson, Arizona, United States
• Steve Sitar, MD — Anaheim, California, United States
• Robert Burton, MD — Anaheim, California, United States
• Arturo Palencia, MD — Bakersfield, California, United States
• Adam Karnes, MD — Beverly Hills, California, United States
• Douglas Haselwood, MD — Fair Oaks, California, United States
• Steven Croft, MD — Delray Beach, Florida, United States
• Roberto Rodriquez, MD — Hialeah, Florida, United States
• Orlando Florete, MD — Jacksonville, Florida, United States
• Michael Link, MD — Kissimmee, Florida, United States
• Miguel Trevino, MD — Largo, Florida, United States
• Diego Torres II, MD — Ormond Beach, Florida, United States
• Martin Hale, MD — Plantation, Florida, United States
• Margarita Nunez, MD — St. Petersburg, Florida, United States
• Mary Stedman, MD — Tampa, Florida, United States
• Raymond Tidman, MD — Blue Ridge, Georgia, United States
• Arnold Weil — Marietta, Georgia, United States
• Marvin Tark — Marietta, Georgia, United States
• Azazuddin Ahmed, MD — Chicago, Illinois, United States
• Jenecsis Castro-Skoglund, MD — Peoria, Illinois, United States
• Steven Elliott, MD — Evansville, Indiana, United States
• Michael Gibson, MD — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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