Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
NCT ID: NCT01428583
Last Updated: 2016-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
395 participants
INTERVENTIONAL
2010-12-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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SUPPORTIVE_CARE
NONE
Study Groups
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oxycodone HCl and naltrexone HCl extended-release capsules
oxycodone HCl and naltrexone HCl extended-release capsules
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)
Interventions
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oxycodone HCl and naltrexone HCl extended-release capsules
Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)
Exclusion Criteria
* Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
* Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
* Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
* Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
* If female, the subject is pregnant or breast-feeding.
* Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
* Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.
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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Avail Clinical Research, LLC
DeLand, Florida, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
Drug Study Institute
Jupiter, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Peninsula Research, Inc.
Ormond Beach, Florida, United States
Accord Clinical Research
Port Orange, Florida, United States
Sarasota Pain Medicine Research
Sarasota, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, United States
Drug Studies America
Marietta, Georgia, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, United States
Crossroads Research
Owings Mills, Maryland, United States
DM Clinical Research
Springfield, Massachusetts, United States
MAPS Applied Research Center
Edina, Minnesota, United States
Mid-South Anesthesia Consultants
Southaven, Mississippi, United States
Healthcare Research, LLC
Hazelwood, Missouri, United States
Montana Neuroscience Institute
Missoula, Montana, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
Drug Trials America - New York
Hartsdale, New York, United States
New York Spine and Wellness Center
North Syracuse, New York, United States
Upstate Clinical Research Associates
Williamsville, New York, United States
Center for Clinical Research, LLC - Winston-Salem
Winston-Salem, North Carolina, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
KRK Medical Research
Dallas, Texas, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Hypothetest, LLC
Roanoke, Virginia, 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.
Arora S, Setnik B, Michael D, Hudson JD, Clemmer R, Meisner P, Pixton GC, Goli V, Sommerville KW. A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain. J Opioid Manag. 2014 Nov-Dec;10(6):423-36. doi: 10.5055/jom.2014.0239.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B4531001
Identifier Type: OTHER
Identifier Source: secondary_id
ALO-02-10-3001
Identifier Type: -
Identifier Source: org_study_id