Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
- Conditions
- Pain
- Interventions
- Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
- Registration Number
- NCT00415597
- Lead Sponsor
- Pfizer
- Brief Summary
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 467
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALO-01 ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) Doses given once or twice daily
- Primary Outcome Measures
Name Time Method Subjects With Treatment Emergent Adverse Events up to 12 months 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).
- Secondary Outcome Measures
Name Time Method Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain 12 weeks 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.
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain 52 weeks 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.
Trial Locations
- Locations (58)
Stephen Miller, MD
🇺🇸Las Vegas, Nevada, United States
Steven Siwek, MD
🇺🇸Phoenix, Arizona, United States
Michael Loes, MD
🇺🇸Phoenix, Arizona, United States
Tanna Shaw, MD
🇺🇸Oklahoma City, Oklahoma, United States
Francis Burch, MD
🇺🇸San Antonio, Texas, United States
Webster Lynn, MD
🇺🇸Salt Lake City, Utah, United States
Bruce Corser, MD
🇺🇸Cincinnati, Ohio, United States
Lawrence Levinson, MD
🇺🇸Tipton, Pennsylvania, United States
Randall Brewer, MD
🇺🇸Shreveport, Louisiana, United States
Diego Torres II, MD
🇺🇸Ormond Beach, Florida, United States
Douglas Haselwood, MD
🇺🇸Fair Oaks, California, United States
David Miller, MD
🇺🇸North Dartmouth, Massachusetts, United States
Margarita Nunez, MD
🇺🇸St. Petersburg, Florida, United States
Arnold Weil
🇺🇸Marietta, Georgia, United States
Miguel Trevino, MD
🇺🇸Largo, Florida, United States
Steven Elliott, MD
🇺🇸Evansville, Indiana, United States
Adnan Dahdul, MD
🇺🇸Springfield, Massachusetts, United States
Robert Kalb, MD
🇺🇸Toledo, Ohio, United States
Randale Sechrest, MD
🇺🇸Missoula, Montana, United States
Rebecca Baumbach, MD
🇺🇸Saginaw, Michigan, United States
Suzanne Gazda, MD
🇺🇸San Antonio, Texas, United States
William Smith, MD
🇺🇸Knoxville, Tennessee, United States
Joseph Dunn, MD
🇺🇸Eugene, Oregon, United States
Leah Schmidt, DO
🇺🇸Tucson, Arizona, United States
Robert Burton, MD
🇺🇸Anaheim, California, United States
Steve Sitar, MD
🇺🇸Anaheim, 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
Martin Hale, MD
🇺🇸Plantation, Florida, United States
Raymond Tidman, MD
🇺🇸Blue Ridge, Georgia, United States
Anthony Margherita, MD
🇺🇸St. Louis, Missouri, United States
Christopher Colopinto, MD
🇺🇸Voorhees, New Jersey, United States
Andrew Klymiuk, MD
🇺🇸Richardson, Texas, United States
Lee Carter, MD
🇺🇸Milan, Tennessee, United States
Adam Karnes, MD
🇺🇸Beverly Hills, California, United States
James Meli, DO
🇺🇸Henderson, Nevada, United States
Allan Soo, MD
🇺🇸Tempe, Arizona, United States
Azazuddin Ahmed, MD
🇺🇸Chicago, Illinois, United States
Patrick Box, MD
🇺🇸Charlotte, North Carolina, United States
Arthur Elkind, MD
🇺🇸Mount Vernon, New York, United States
Arturo Palencia, MD
🇺🇸Bakersfield, California, United States
Vrijendra Kumar, MD
🇺🇸Las Vegas, Nevada, United States
Marvin Tark
🇺🇸Marietta, Georgia, United States
Mel Lucas, MD
🇺🇸Florissant, Missouri, United States
John Peppin, DO
🇺🇸West Des Moines, Iowa, United States
Gregory Gottschlich, MD
🇺🇸Cincinatti, Ohio, United States
Michael Gibson, MD
🇺🇸Birmingham, Alabama, United States
Mary Stedman, MD
🇺🇸Tampa, Florida, United States
John Jacobson, MD
🇺🇸Omaha, Nebraska, United States
Barbara McGuire, MD
🇺🇸Albuquerque, New Mexico, United States
Richard Rauck, MD
🇺🇸Winston-Salem, North Carolina, United States
Thomas Littlejohn III, MD
🇺🇸Winston-Salem, North Carolina, United States
Walter Chase, MD
🇺🇸Austin, Texas, United States
Jenecsis Castro-Skoglund, MD
🇺🇸Peoria, Illinois, United States
Richard Eckert, MD
🇺🇸Roanoke, Virginia, United States
William Travis Ellison, MD
🇺🇸Greer, South Carolina, United States