Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
Public ClinicalTrials.gov record NCT02101554. 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 SAFETY AND PHARMACOKINETICS OF PF-06412528 IN CHILDREN 7-17 YEARS FOR THE TREATMENT OF MODERATE-TO-SEVERE PAIN
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Study identification
- NCT ID
- NCT02101554
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 19 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
- Apr 24, 2015 (Actual)
- Primary completion
- Jun 26, 2019 (Actual)
- Completion
- Jun 26, 2019 (Actual)
- Last update posted
- Jul 10, 2020
2015 – 2019
United States locations
- U.S. sites
- 19
- U.S. states
- 5
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Gottschalk Medical Plaza | Irvine | California | 92697 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| The University of California, Irvine Health - Medical Specialties | Orange | California | 92868 | — |
| UCI Medical Center- Outpatient Pharmacy | Orange | California | 92868 | — |
| University of California, Irvine Health-Inpatient Pharmacy | Orange | California | 92868 | — |
| University of California, Irvine Health-Medical Specialties | Orange | California | 92868 | — |
| Holtz Children Hospital/Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Jackson Memorial Hospital - Pharmacy Department Basement West | Miami | Florida | 33136 | — |
| Sylvester Comprehensive Cancer Center-Alex's Place | Miami | Florida | 33136 | — |
| University of Miami / Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Veritas Research Corp. | Miami Lakes | Florida | 33014 | — |
| University of Illinois at Chicago Clinical Research Center | Chicago | Illinois | 60612 | — |
| University of Illinois at the Med Center, University of Illinois | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | — |
| East Carolina University Brody School of Medicine(ECU) | Greenville | North Carolina | 27834 | — |
| Leo Jenkins Cancer Center Pharmacy Attn: Rebecca Turnage | Greenville | North Carolina | 27834 | — |
| Primary Children's Hospital Outpatient Services | Salt Lake City | Utah | 84113 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
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 NCT02101554, 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 Jul 10, 2020 · Synced Nov 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02101554 live on ClinicalTrials.gov.