Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

Stopped early · Phase 4

Conditions studied: Moderate-severe Pain

In brief

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.

Key facts

Study ID

NCT02101554

Run by

Pfizer

People needed

19

Starts

2015-04-24

Expected to finish

2019-06-26

Last updated by the study team

2020-07-10

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
• Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to >20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.

You may not qualify if…

• Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
• 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.

Where it is running

• Gottschalk Medical Plaza — Irvine, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• The University of California, Irvine Health - Medical Specialties — Orange, California, United States
• UCI Medical Center- Outpatient Pharmacy — Orange, California, United States
• University of California, Irvine Health-Inpatient Pharmacy — Orange, California, United States
• University of California, Irvine Health-Medical Specialties — Orange, California, United States
• Holtz Children Hospital/Jackson Memorial Hospital — Miami, Florida, United States
• Jackson Memorial Hospital - Pharmacy Department Basement West — Miami, Florida, United States
• Sylvester Comprehensive Cancer Center-Alex's Place — Miami, Florida, United States
• University of Miami / Jackson Memorial Hospital — Miami, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Veritas Research Corp. — Miami Lakes, Florida, United States
• University of Illinois at Chicago Clinical Research Center — Chicago, Illinois, United States
• University of Illinois at the Med Center, University of Illinois — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States
• East Carolina University Brody School of Medicine(ECU) — Greenville, North Carolina, United States
• Leo Jenkins Cancer Center Pharmacy Attn: Rebecca Turnage — Greenville, North Carolina, United States
• Primary Children's Hospital Outpatient Services — Salt Lake City, Utah, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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