A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
NCT ID: NCT01571362
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2012-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALO-02
ALO-02
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
Placebo
Placebo
oral placebo, divided into symmetric doses and administered twice daily
Interventions
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ALO-02
20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
Placebo
oral placebo, divided into symmetric doses and administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require a continuous around-the-clock opioid analgesic for an extended period of time.
* Refrain from taking other opioid and non-opioid medications during the study.
Exclusion Criteria
* Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain.
* Active or ongoing or history of alcohol or drug abuse.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Premier Research Group Limited
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Med Center
Carmichael, California, United States
Med Investigations, Inc.
Fair Oaks, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Pacific Coast Pain Management Center
Laguna Hills, California, United States
Long Beach Center for Clinical Research - previous addresse
Long Beach, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Providence Clinical Research
North Hollywood, California, United States
Clinicos, LLC
Colorado Springs, Colorado, United States
Lynn Institute of the Rockies Medical Centre
Colorado Springs, Colorado, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Ormond Medical Arts pharmaceutical Research Center
Ormond Beach, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
The Office of Martin E. Hale, MD, PA
Plantation, Florida, United States
Accord Clinical Research, LLC- Duplicate 2
Port Orange, Florida, United States
Accord Clinical Research, LLC- Duplicate
Port Orange, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Mid-Atlantic Medical Research - Research Department
Hollywood, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Mercy Health Research
St Louis, Missouri, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States
Office of Stephen H. Miller, M.D.
Las Vegas, Nevada, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Drug Trials America
Hartsdale, New York, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Research Across America
New York, New York, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, United States
The Center for Clinical Research
Winston-Salem, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Columbus Clinical Research
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Associated Orthopedics
Oklahoma City, Oklahoma, United States
Hillcrest Clinical Research
Oklahoma City, Oklahoma, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Pain Research of Charleston
Charleston, South Carolina, United States
TLM Medical Services
Columbia, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
Lee Medical Associates
San Antonio, Texas, United States
Progressive Clinical Research, P.A.
San Antonio, Texas, United States
Countries
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References
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Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.
Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.
Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.
Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4531002
Identifier Type: -
Identifier Source: secondary_id
ALO-02-10-3002
Identifier Type: OTHER
Identifier Source: secondary_id
B4531002
Identifier Type: -
Identifier Source: org_study_id
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