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

NCT ID: NCT00415597

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 467 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

Brief Summary

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

Conditions

Pain

Keywords

chronic pain; joint pain; back pain; diabetic peripheral neuropathy; post herpetic neuralgia; ALO-01; Embeda; Chronic Non-Malignant Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ALO-01

Doses given once or twice daily

Group Type: EXPERIMENTAL

ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Embeda

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James B. Jones, MD, PharmD

Role: STUDY_DIRECTOR

Alpharma Pharmaceuticals

Locations

Michael Gibson, MD

Birmingham, Alabama, United States

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

John Peppin, DO

West Des Moines, Iowa, United States

Randall Brewer, MD

Shreveport, Louisiana, United States

David Miller, MD

North Dartmouth, Massachusetts, United States

Adnan Dahdul, MD

Springfield, Massachusetts, United States

Rebecca Baumbach, MD

Saginaw, Michigan, United States

Mel Lucas, MD

Florissant, Missouri, United States

Anthony Margherita, MD

St Louis, Missouri, United States

Randale Sechrest, MD

Missoula, Montana, United States

John Jacobson, MD

Omaha, Nebraska, United States

James Meli, DO

Henderson, Nevada, United States

Stephen Miller, MD

Las Vegas, Nevada, United States

Vrijendra Kumar, MD

Las Vegas, Nevada, United States

Christopher Colopinto, MD

Voorhees Township, New Jersey, United States

Barbara McGuire, MD

Albuquerque, New Mexico, United States

Arthur Elkind, MD

Mount Vernon, New York, United States

Patrick Box, MD

Charlotte, North Carolina, United States

Richard Rauck, MD

Winston-Salem, North Carolina, United States

Thomas Littlejohn III, MD

Winston-Salem, North Carolina, United States

Bruce Corser, MD

Cincinnati, Ohio, United States

Gregory Gottschlich, MD

Cincinnati, Ohio, United States

Robert Kalb, MD

Toledo, Ohio, United States

Tanna Shaw, MD

Oklahoma City, Oklahoma, United States

Joseph Dunn, MD

Eugene, Oregon, United States

Lawrence Levinson, MD

Tipton, Pennsylvania, United States

William Travis Ellison, MD

Greer, South Carolina, United States

William Smith, MD

Knoxville, Tennessee, United States

Lee Carter, MD

Milan, Tennessee, United States

Walter Chase, MD

Austin, Texas, United States

Andrew Klymiuk, MD

Richardson, Texas, United States

Francis Burch, MD

San Antonio, Texas, United States

Suzanne Gazda, MD

San Antonio, Texas, United States

Webster Lynn, MD

Salt Lake City, Utah, United States

Richard Eckert, MD

Roanoke, Virginia, United States

Countries

United States

References

Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.

Reference Type: DERIVED

PMID: 26695349 (View on PubMed)

Webster LR, Brewer R, Morris D, Cleveland JM, Setnik B. Opioid titration and conversion in patients receiving morphine sulfate and naltrexone hydrochloride extended release capsules. Postgrad Med. 2011 Sep;123(5):155-64. doi: 10.3810/pgm.2011.09.2471.

Reference Type: DERIVED

PMID: 21904098 (View on PubMed)

Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J. Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010 Nov;40(5):734-46. doi: 10.1016/j.jpainsymman.2010.05.004.

Reference Type: DERIVED

PMID: 21075272 (View on PubMed)

Other Identifiers

ALO-KNT-302

Identifier Type: -

Identifier Source: org_study_id