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

Condition(s) targeted: Pain

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

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
James B. Jones, MD, PharmD, Study Director, Affiliation: Alpharma Pharmaceuticals

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

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Subjects With Treatment Emergent Adverse Events

Secondary outcome:

Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Michael Gibson, MD, Birmingham, Alabama 35244, United States

Michael Loes, MD, Phoenix, Arizona 85032, United States

Steven Siwek, MD, Phoenix, Arizona 85027, United States

Allan Soo, MD, Tempe, Arizona 85282, United States

Leah Schmidt, DO, Tucson, Arizona 85741, United States

Robert Burton, MD, Anaheim, California 92804, United States

Steve Sitar, MD, Anaheim, California 92801, United States

Arturo Palencia, MD, Bakersfield, California 93311, United States

Adam Karnes, MD, Beverly Hills, California 90211, United States

Douglas Haselwood, MD, Fair Oaks, California 95628, United States

Steven Croft, MD, Delray Beach, Florida 33484, United States

Roberto Rodriquez, MD, Hialeah, Florida 33013, United States

Orlando Florete, MD, Jacksonville, Florida 32257, United States

Michael Link, MD, Kissimmee, Florida 34741, United States

Miguel Trevino, MD, Largo, Florida 33770, United States

Diego Torres II, MD, Ormond Beach, Florida 32174, United States

Martin Hale, MD, Plantation, Florida 33324, United States

Margarita Nunez, MD, St. Petersburg, Florida 33702, United States

Mary Stedman, MD, Tampa, Florida 33613, United States

Raymond Tidman, MD, Blue Ridge, Georgia 30513, United States

Arnold Weil, Marietta, Georgia 30060, United States

Marvin Tark, Marietta, Georgia 30066, United States

Azazuddin Ahmed, MD, Chicago, Illinois 60616, United States

Jenecsis Castro-Skoglund, MD, Peoria, Illinois 61614, United States

Steven Elliott, MD, Evansville, Indiana 47714, United States

John Peppin, DO, West Des Moines, Iowa 50265, United States

Randall Brewer, MD, Shreveport, Louisiana 71103, United States

David Miller, MD, North Dartmouth, Massachusetts 02747, United States

Adnan Dahdul, MD, Springfield, Massachusetts 01103, United States

Rebecca Baumbach, MD, Saginaw, Michigan 48602, United States

Mel Lucas, MD, Florissant, Missouri 63031, United States

Anthony Margherita, MD, St. Louis, Missouri 63141, United States

Randale Sechrest, MD, Missoula, Montana 59802, United States

John Jacobson, MD, Omaha, Nebraska 68134, United States

James Meli, DO, Henderson, Nevada 89014, United States

Stephen Miller, MD, Las Vegas, Nevada 89106, United States

Vrijendra Kumar, MD, Las Vegas, Nevada 89123, United States

Christopher Colopinto, MD, Voorhees, New Jersey 08043, United States

Barbara McGuire, MD, Albuquerque, New Mexico 87108, United States

Arthur Elkind, MD, Mount Vernon, New York 10550, United States

Patrick Box, MD, Charlotte, North Carolina 28210, United States

Richard Rauck, MD, Winston-Salem, North Carolina 27103, United States

Thomas Littlejohn III, MD, Winston-Salem, North Carolina 27103, United States

Gregory Gottschlich, MD, Cincinatti, Ohio 45242, United States

Bruce Corser, MD, Cincinnati, Ohio 45227, United States

Robert Kalb, MD, Toledo, Ohio 43623, United States

Tanna Shaw, MD, Oklahoma City, Oklahoma 73116, United States

Joseph Dunn, MD, Eugene, Oregon 97401, United States

Lawrence Levinson, MD, Tipton, Pennsylvania 16684, United States

William Travis Ellison, MD, Greer, South Carolina 29651, United States

William Smith, MD, Knoxville, Tennessee 37920, United States

Lee Carter, MD, Milan, Tennessee 38358, United States

Walter Chase, MD, Austin, Texas 78705, United States

Andrew Klymiuk, MD, Richardson, Texas 75080, United States

Francis Burch, MD, San Antonio, Texas 78217, United States

Suzanne Gazda, MD, San Antonio, Texas 78229, United States

Webster Lynn, MD, Salt Lake City, Utah 84106, United States

Richard Eckert, MD, Roanoke, Virginia 24018, United States

Starting date: December 2006
Last updated: September 13, 2013