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

NCT00415597 | Completed Phase 3 Results

• 1 other identifier: ALO-KNT-302
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 58

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

Outcome Measures

Primary Outcomes (1)

• Subjects With Treatment Emergent Adverse Events

  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).

  up to 12 months

Secondary Outcomes (2)

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

  12 weeks

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

  52 weeks

Study Arms (1)

ALO-01

EXPERIMENTAL

Doses given once or twice daily

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

Interventions

ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) 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

Also known as: Embeda

ALO-01

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (58)

Michael Gibson, MD

Birmingham, Alabama, 35244, United States

Location

Steven Siwek, MD

Phoenix, Arizona, 85027, United States

Location

Michael Loes, MD

Phoenix, Arizona, 85032, United States

Location

Allan Soo, MD

Tempe, Arizona, 85282, United States

Location

Leah Schmidt, DO

Tucson, Arizona, 85741, United States

Location

Steve Sitar, MD

Anaheim, California, 92801, United States

Location

Robert Burton, MD

Anaheim, California, 92804, United States

Location

Arturo Palencia, MD

Bakersfield, California, 93311, United States

Location

Adam Karnes, MD

Beverly Hills, California, 90211, United States

Location

Douglas Haselwood, MD

Fair Oaks, California, 95628, United States

Location

Steven Croft, MD

Delray Beach, Florida, 33484, United States

Location

Roberto Rodriquez, MD

Hialeah, Florida, 33013, United States

Location

Orlando Florete, MD

Jacksonville, Florida, 32257, United States

Location

Michael Link, MD

Kissimmee, Florida, 34741, United States

Location

Miguel Trevino, MD

Largo, Florida, 33770, United States

Location

Diego Torres II, MD

Ormond Beach, Florida, 32174, United States

Location

Martin Hale, MD

Plantation, Florida, 33324, United States

Location

Margarita Nunez, MD

St. Petersburg, Florida, 33702, United States

Location

Mary Stedman, MD

Tampa, Florida, 33613, United States

Location

Raymond Tidman, MD

Blue Ridge, Georgia, 30513, United States

Location

Arnold Weil

Marietta, Georgia, 30060, United States

Location

Marvin Tark

Marietta, Georgia, 30066, United States

Location

Azazuddin Ahmed, MD

Chicago, Illinois, 60616, United States

Location

Jenecsis Castro-Skoglund, MD

Peoria, Illinois, 61614, United States

Location

Steven Elliott, MD

Evansville, Indiana, 47714, United States

Location

John Peppin, DO

West Des Moines, Iowa, 50265, United States

Location

Randall Brewer, MD

Shreveport, Louisiana, 71103, United States

Location

David Miller, MD

North Dartmouth, Massachusetts, 02747, United States

Location

Adnan Dahdul, MD

Springfield, Massachusetts, 01103, United States

Location

Rebecca Baumbach, MD

Saginaw, Michigan, 48602, United States

Location

Mel Lucas, MD

Florissant, Missouri, 63031, United States

Location

Anthony Margherita, MD

St Louis, Missouri, 63141, United States

Location

Randale Sechrest, MD

Missoula, Montana, 59802, United States

Location

John Jacobson, MD

Omaha, Nebraska, 68134, United States

Location

James Meli, DO

Henderson, Nevada, 89014, United States

Location

Stephen Miller, MD

Las Vegas, Nevada, 89106, United States

Location

Vrijendra Kumar, MD

Las Vegas, Nevada, 89123, United States

Location

Christopher Colopinto, MD

Voorhees Township, New Jersey, 08043, United States

Location

Barbara McGuire, MD

Albuquerque, New Mexico, 87108, United States

Location

Arthur Elkind, MD

Mount Vernon, New York, 10550, United States

Location

Patrick Box, MD

Charlotte, North Carolina, 28210, United States

Location

Richard Rauck, MD

Winston-Salem, North Carolina, 27103, United States

Location

Thomas Littlejohn III, MD

Winston-Salem, North Carolina, 27103, United States

Location

Bruce Corser, MD

Cincinnati, Ohio, 45227, United States

Location

Gregory Gottschlich, MD

Cincinnati, Ohio, 45242, United States

Location

Robert Kalb, MD

Toledo, Ohio, 43623, United States

Location

Tanna Shaw, MD

Oklahoma City, Oklahoma, 73116, United States

Location

Joseph Dunn, MD

Eugene, Oregon, 97401, United States

Location

Lawrence Levinson, MD

Tipton, Pennsylvania, 16684, United States

Location

William Travis Ellison, MD

Greer, South Carolina, 29651, United States

Location

William Smith, MD

Knoxville, Tennessee, 37920, United States

Location

Lee Carter, MD

Milan, Tennessee, 38358, United States

Location

Walter Chase, MD

Austin, Texas, 78705, United States

Location

Andrew Klymiuk, MD

Richardson, Texas, 75080, United States

Location

Francis Burch, MD

San Antonio, Texas, 78217, United States

Location

Suzanne Gazda, MD

San Antonio, Texas, 78229, United States

Location

Webster Lynn, MD

Salt Lake City, Utah, 84106, United States

Location

Richard Eckert, MD

Roanoke, Virginia, 24018, United States

Location

Related Publications (3)

• 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.

  PMID: 26695349 DERIVED

• 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.

  PMID: 21904098 DERIVED

• 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.

  PMID: 21075272 DERIVED

MeSH Terms

Conditions

Pain; Chronic Pain; Arthralgia; Back Pain; Neuralgia, Postherpetic

Interventions

morphine, naltrexone combination; Morphine; Naltrexone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Results Point of Contact

• Title: Vice President, Clinical Development
• Organization: King Pharmaceuticals Research and Development, Inc.

919-653-7001

Study Officials

• James B. Jones, MD, PharmD

  Alpharma Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2006
• First Posted: December 25, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: September 20, 2013
• Results First Posted: October 29, 2009

Record last verified: 2013-09

Locations

US (58)