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

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)

• Study Type: Interventional
• Enrollment (Actual): 467
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALO-01; Doses given once or twice daily	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; Other Names: Embeda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	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.	12 weeks
Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	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.	52 weeks

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: James B. Jones, MD, PharmD, Alpharma Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: December 21, 2006
• First Submitted That Met QC Criteria: December 21, 2006
• First Posted (Estimate): December 25, 2006

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 13, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: chronic pain; joint pain; back pain; post herpetic neuralgia; Embeda; diabetic peripheral neuropathy; Chronic Non-Malignant Pain; ALO-01
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Morphine
• Other Study ID Numbers: ALO-KNT-302