Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Public ClinicalTrials.gov record NCT02680847. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Study identification
- NCT ID
- NCT02680847
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2016
- Primary completion
- Jan 9, 2018
- Completion
- Jan 23, 2018
- Last update posted
- Sep 24, 2018
2016 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Center For Clinical Studies-West, Inc. | Lancaster | California | 93534 | — |
| Children's Hopsital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine | Los Angeles | California | 90027 | — |
| Shriners Hospitals For Children Northern California | Sacramento | California | 95817 | — |
| UC Davis Health Attn: Peter Trovitch, PharmD | Sacramento | California | 95817 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| University of Illinois at Chicago Clinical Research Center | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Sciences Systems | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital at the Medical Center | Chicago | Illinois | 60612 | — |
| East Carolina University Brody School of Medicine(ECU) | Greenville | North Carolina | 27834 | — |
| Leo Jenkins Cancer Center Pharmacy | Greenville | North Carolina | 27834 | — |
| Medical University of South Carolina Children's Hospital | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina, Investigational Drugs Services | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina, Rutledge Tower, Pediatric Clinic | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina, SCTR Research Nexus | Charleston | South Carolina | 29425 | — |
| Road Runner Research, Ltd | San Antonio | Texas | 78249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02680847, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 24, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02680847 live on ClinicalTrials.gov.