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

Sponsor:	Alpharma Inc.
Information provided by:	Alpharma Inc.
ClinicalTrials.gov Identifier:	NCT00415597

Purpose

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

Condition	Intervention	Phase
Pain	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Alpharma Inc.:

Primary Outcome Measures:

Subjects With Treatment Emergent Adverse Events [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Mean Percent Change From Baseline in Brief Pain Inventory Score (BPI) of Average Pain [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	467
Study Start Date:	December 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ALO-01: Experimental	Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415597

Hide Study Locations

Locations

United States, Alabama
Michael Gibson, MD
Birmingham, Alabama, United States, 35244
United States, Arizona
Michael Loes, MD
Phoenix, Arizona, United States, 85032
Leah Schmidt, DO
Tucson, Arizona, United States, 85741
Steven Siwek, MD
Phoenix, Arizona, United States, 85027
Allan Soo, MD
Tempe, Arizona, United States, 85282
United States, California
Robert Burton, MD
Anaheim, California, United States, 92804
Douglas Haselwood, MD
Fair Oaks, California, United States, 95628
Adam Karnes, MD
Beverly Hills, California, United States, 90211
Arturo Palencia, MD
Bakersfield, California, United States, 93311
Steve Sitar, MD
Anaheim, California, United States, 92801
United States, Florida
Steven Croft, MD
Delray Beach, Florida, United States, 33484
Roberto Rodriquez, MD
Hialeah, Florida, United States, 33013
Martin Hale, MD
Plantation, Florida, United States, 33324
Orlando Florete, MD
Jacksonville, Florida, United States, 32257
Michael Link, MD
Kissimmee, Florida, United States, 34741
Margarita Nunez, MD
St. Petersburg, Florida, United States, 33702
Mary Stedman, MD
Tampa, Florida, United States, 33613
Diego Torres II, MD
Ormond Beach, Florida, United States, 32174
Miguel Trevino, MD
Largo, Florida, United States, 33770
United States, Georgia
Marvin Tark
Marietta, Georgia, United States, 30066
Raymond Tidman, MD
Blue Ridge, Georgia, United States, 30513
Arnold Weil
Marietta, Georgia, United States, 30060
United States, Illinois
Azazuddin Ahmed, MD
Chicago, Illinois, United States, 60616
Jenecsis Castro-Skoglund, MD
Peoria, Illinois, United States, 61614
United States, Indiana
Steven Elliott, MD
Evansville, Indiana, United States, 47714
United States, Iowa
John Peppin, DO
West Des Moines, Iowa, United States, 50265
United States, Louisiana
Randall Brewer, MD
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Adnan Dahdul, MD
Springfield, Massachusetts, United States, 01103
David Miller, MD
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Rebecca Baumbach, MD
Saginaw, Michigan, United States, 48602
United States, Missouri
Mel Lucas, MD
Florissant, Missouri, United States, 63031
Anthony Margherita, MD
St. Louis, Missouri, United States, 63141
United States, Montana
Randale Sechrest, MD
Missoula, Montana, United States, 59802
United States, Nebraska
John Jacobson, MD
Omaha, Nebraska, United States, 68134
United States, Nevada
Vrijendra Kumar, MD
Las Vegas, Nevada, United States, 89123
James Meli, DO
Henderson, Nevada, United States, 89014
Stephen Miller, MD
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Christopher Colopinto, MD
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Barbara McGuire, MD
Albuquerque, New Mexico, United States, 87108
United States, New York
Arthur Elkind, MD
Mount Vernon, New York, United States, 10550
United States, North Carolina
Patrick Box, MD
Charlotte, North Carolina, United States, 28210
Thomas Littlejohn III, MD
Winston-Salem, North Carolina, United States, 27103
Richard Rauck, MD
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Bruce Corser, MD
Cincinnati, Ohio, United States, 45227
Gregory Gottschlich, MD
Cincinatti, Ohio, United States, 45242
Robert Kalb, MD
Toledo, Ohio, United States, 43623
United States, Oklahoma
Tanna Shaw, MD
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Joseph Dunn, MD
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Lawrence Levinson, MD
Tipton, Pennsylvania, United States, 16684
United States, South Carolina
William Travis Ellison, MD
Greer, South Carolina, United States, 29651
United States, Tennessee
Lee Carter, MD
Milan, Tennessee, United States, 38358
William Smith, MD
Knoxville, Tennessee, United States, 37920
United States, Texas
Francis Burch, MD
San Antonio, Texas, United States, 78217
Walter Chase, MD
Austin, Texas, United States, 78705
Suzanne Gazda, MD
San Antonio, Texas, United States, 78229
Andrew Klymiuk, MD
Richardson, Texas, United States, 75080
United States, Utah
Webster Lynn, MD
Salt Lake City, Utah, United States, 84106
United States, Virginia
Richard Eckert, MD
Roanoke, Virginia, United States, 24018

Sponsors and Collaborators

Alpharma Inc.

Investigators

Study Director:

James B. Jones, MD, PharmD

Alpharma Pharmaceuticals

More Information

No publications provided

Responsible Party:	King Pharmaceuticals Research and Development, Inc. ( Kenneth Sommerville, M.D., FAAN, Vice President, Clinical Development )
Study ID Numbers:	ALO-KNT-302
Study First Received:	December 21, 2006
Results First Received:	September 11, 2009
Last Updated:	October 28, 2009
ClinicalTrials.gov Identifier:	NCT00415597 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alpharma Inc.:

chronic pain
joint pain
back pain
diabetic peripheral neuropathy

post herpetic neuralgia
ALO-01
Embeda
Chronic Non-Malignant Pain

Additional relevant MeSH terms:

Morphine
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Sensory System Agents

Therapeutic Uses
Naltrexone
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009