Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
NCT ID: NCT02680847
Last Updated: 2018-09-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
32 participants
INTERVENTIONAL
2016-01-21
2018-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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ALO-02
One arm, open label, active
ALO-02
Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Interventions
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ALO-02
Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \> 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.
Exclusion Criteria
* Hypersensitivity to morphine, naltrexone.
* A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
* Undergone surgery within 3 days prior to the first day of dosing.
7 Years
17 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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Research Center For Clinical Studies-West, Inc.
Lancaster, California, United States
Children's Hopsital Los Angeles
Los Angeles, California, United States
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, United States
Shriners Hospitals For Children Northern California
Sacramento, California, United States
UC Davis Health Attn: Peter Trovitch, PharmD
Sacramento, California, United States
University of California Davis
Sacramento, California, United States
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, United States
University of Illinois Hospital at the Medical Center
Chicago, Illinois, United States
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, United States
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
Medical University of South Carolina, Investigational Drugs Services
Charleston, South Carolina, United States
Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
Charleston, South Carolina, United States
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, United States
Road Runner Research, Ltd
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
Other Identifiers
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ALO-02 PHASE 4 PEDIATRIC STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
B4531015
Identifier Type: -
Identifier Source: org_study_id
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