Clinical trial NCT00415597: Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: chronic pain
joint pain
back pain
diabetic peripheral neuropathy
post herpetic neuralgia
ALO-01
Embeda
Chronic Non-Malignant Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Subjects With Treatment Emergent Adverse Events
timeFrame: up to 12 months
Secondary outcomes:
measure: Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
timeFrame: 12 weeks
measure: Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Michael Gibson, MD
state: Alabama
city: Phoenix
country: United States
facility: Steven Siwek, MD
state: Arizona
city: Phoenix
country: United States
facility: Michael Loes, MD
state: Arizona
city: Tempe
country: United States
facility: Allan Soo, MD
state: Arizona
city: Tucson
country: United States
facility: Leah Schmidt, DO
state: Arizona
city: Anaheim
country: United States
facility: Steve Sitar, MD
state: California
city: Anaheim
country: United States
facility: Robert Burton, MD
state: California
city: Bakersfield
country: United States
facility: Arturo Palencia, MD
state: California
city: Beverly Hills
country: United States
facility: Adam Karnes, MD
state: California
city: Fair Oaks
country: United States
facility: Douglas Haselwood, MD
state: California
city: Delray Beach
country: United States
facility: Steven Croft, MD
state: Florida
city: Hialeah
country: United States
facility: Roberto Rodriquez, MD
state: Florida
city: Jacksonville
country: United States
facility: Orlando Florete, MD
state: Florida
city: Kissimmee
country: United States
facility: Michael Link, MD
state: Florida
city: Largo
country: United States
facility: Miguel Trevino, MD
state: Florida
city: Ormond Beach
country: United States
facility: Diego Torres II, MD
state: Florida
city: Plantation
country: United States
facility: Martin Hale, MD
state: Florida
city: St. Petersburg
country: United States
facility: Margarita Nunez, MD
state: Florida
city: Tampa
country: United States
facility: Mary Stedman, MD
state: Florida
city: Blue Ridge
country: United States
facility: Raymond Tidman, MD
state: Georgia
city: Marietta
country: United States
facility: Arnold Weil
state: Georgia
city: Marietta
country: United States
facility: Marvin Tark
state: Georgia
city: Chicago
country: United States
facility: Azazuddin Ahmed, MD
state: Illinois
city: Peoria
country: United States
facility: Jenecsis Castro-Skoglund, MD
state: Illinois
city: Evansville
country: United States
facility: Steven Elliott, MD
state: Indiana
city: West Des Moines
country: United States
facility: John Peppin, DO
state: Iowa
city: Shreveport
country: United States
facility: Randall Brewer, MD
state: Louisiana
city: North Dartmouth
country: United States
facility: David Miller, MD
state: Massachusetts
city: Springfield
country: United States
facility: Adnan Dahdul, MD
state: Massachusetts
city: Saginaw
country: United States
facility: Rebecca Baumbach, MD
state: Michigan
city: Florissant
country: United States
facility: Mel Lucas, MD
state: Missouri
city: St. Louis
country: United States
facility: Anthony Margherita, MD
state: Missouri
city: Missoula
country: United States
facility: Randale Sechrest, MD
state: Montana
city: Omaha
country: United States
facility: John Jacobson, MD
state: Nebraska
city: Henderson
country: United States
facility: James Meli, DO
state: Nevada
city: Las Vegas
country: United States
facility: Stephen Miller, MD
state: Nevada
city: Las Vegas
country: United States
facility: Vrijendra Kumar, MD
state: Nevada
city: Voorhees
country: United States
facility: Christopher Colopinto, MD
state: New Jersey
city: Albuquerque
country: United States
facility: Barbara McGuire, MD
state: New Mexico
city: Mount Vernon
country: United States
facility: Arthur Elkind, MD
state: New York
city: Charlotte
country: United States
facility: Patrick Box, MD
state: North Carolina
city: Winston-Salem
country: United States
facility: Richard Rauck, MD
state: North Carolina
city: Winston-Salem
country: United States
facility: Thomas Littlejohn III, MD
state: North Carolina
city: Cincinatti
country: United States
facility: Gregory Gottschlich, MD
state: Ohio
city: Cincinnati
country: United States
facility: Bruce Corser, MD
state: Ohio
city: Toledo
country: United States
facility: Robert Kalb, MD
state: Ohio
city: Oklahoma City
country: United States
facility: Tanna Shaw, MD
state: Oklahoma
city: Eugene
country: United States
facility: Joseph Dunn, MD
state: Oregon
city: Tipton
country: United States
facility: Lawrence Levinson, MD
state: Pennsylvania
city: Greer
country: United States
facility: William Travis Ellison, MD
state: South Carolina
city: Knoxville
country: United States
facility: William Smith, MD
state: Tennessee
city: Milan
country: United States
facility: Lee Carter, MD
state: Tennessee
city: Austin
country: United States
facility: Walter Chase, MD
state: Texas
city: Richardson
country: United States
facility: Andrew Klymiuk, MD
state: Texas
city: San Antonio
country: United States
facility: Francis Burch, MD
state: Texas
city: San Antonio
country: United States
facility: Suzanne Gazda, MD
state: Texas
city: Salt Lake City
country: United States
facility: Webster Lynn, MD
state: Utah
city: Roanoke
country: United States
facility: Richard Eckert, MD
state: Virginia
Study officials:
affiliation: Alpharma Pharmaceuticals
name: James B. Jones, MD, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.