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



Status:Recruiting
Healthy:No
Age Range:7 - 17
Updated:3/17/2019
Start Date:April 24, 2015
End Date:December 21, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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.

Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study
duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last
dose.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Anaheim, California 92805
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1740 West Taylor Street
Chicago, Illinois 60612
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Gainesville, Florida 32608
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Greenville, North Carolina 27834
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Irvine, California 92697
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Lancaster, California 93534
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1475 Northwest 12th Avenue
Miami, Florida 33136
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1400 Northwest 12th Avenue
Miami, Florida 33136
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1611 Northwest 12th Avenue
Miami, Florida 33136
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1611 Northwest 12th Avenue
Miami, Florida 33136
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Miami Lakes, Florida 33014
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101 The City Drive South
Orange, California 92868
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101 The City Drive South
Orange, California 92868
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101 The City Drive South
Orange, California 92868
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