Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain
2 other identifiers
interventional
395
1 country
32
Brief Summary
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2010
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 2, 2011
CompletedFirst Posted
Study publicly available on registry
September 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
November 21, 2016
CompletedNovember 21, 2016
June 1, 2016
1.4 years
September 2, 2011
September 28, 2016
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to end of study (2 weeks post-end of month 12)
Secondary Outcomes (3)
Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity
Baseline up to end of study (2 weeks post-end of month 12)
Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score
Baseline up to Month 12
Subjective Opiate Withdrawal Scale (SOWS) Score
Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other Outcomes (15)
Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone
Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone
Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone
Week 1, 4, Month 2, 3, 6, 9, 12 or early termination
- +12 more other outcomes
Study Arms (1)
oxycodone HCl and naltrexone HCl extended-release capsules
EXPERIMENTALInterventions
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.)
Eligibility Criteria
You may qualify if:
- Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
- 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.)
You may not qualify if:
- Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32257, United States
Drug Study Institute
Jupiter, Florida, 33458, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
Accord Clinical Research
Port Orange, Florida, 32129, United States
Sarasota Pain Medicine Research
Sarasota, Florida, 34238, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, 30327, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431, United States
Crossroads Research
Owings Mills, Maryland, 21117, United States
DM Clinical Research
Springfield, Massachusetts, 01103, United States
MAPS Applied Research Center
Edina, Minnesota, 55435, United States
Mid-South Anesthesia Consultants
Southaven, Mississippi, 38671, United States
Healthcare Research, LLC
Hazelwood, Missouri, 64042, United States
Montana Neuroscience Institute
Missoula, Montana, 59802, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Drug Trials America - New York
Hartsdale, New York, 10530, United States
New York Spine and Wellness Center
North Syracuse, New York, 13212, United States
Upstate Clinical Research Associates
Williamsville, New York, 14221, United States
Center for Clinical Research, LLC - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, 16602, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
KRK Medical Research
Dallas, Texas, 75230, United States
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Hypothetest, LLC
Roanoke, Virginia, 24018, United States
Related Publications (3)
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.
PMID: 31849032DERIVEDWilson 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.
PMID: 31456431DERIVEDArora 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.
PMID: 25531960DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Outcome measure reporting of Participants With Response to Urine Drug Test were based on qualitative point of contact results only.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2011
First Posted
September 5, 2011
Study Start
December 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
November 21, 2016
Results First Posted
November 21, 2016
Record last verified: 2016-06