Clinical trial NCT02101554: Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Moderate-severe Pain
Keywords: Pediatric
pain indication
controlled release morphine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 19
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 1 to Week 4
timeFrame: Week 1 to Week 4
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 5 to Week 10
timeFrame: Week 5 to Week 10
measure: Number of Participants With Treatment Emergent Adverse Events According to Severity: Week 1 to Week 4
timeFrame: Week 1 to Week 4
measure: Number of Participants With Treatment Emergent Adverse Events According to Severity: Week 5 to Week 10
timeFrame: Week 5 to Week 10
measure: Number of Participants With Treatment Emergent Treatment Related Adverse Events: Week 1 to Week 4
timeFrame: Week 1 to Week 4
measure: Number of Participants With Treatment Emergent Treatment Related Adverse Events: Week 5 to Week 10
timeFrame: Week 5 to Week 10
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Screening Before Day 1
timeFrame: At Screening (2 weeks before Day 1 of study)
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Day 1
timeFrame: Day 1 (Pre-dose)
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 1
timeFrame: Week 1
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 2
timeFrame: Week 2
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 3
timeFrame: Week 3
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 4
timeFrame: Week 4
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Early Termination Before Week 4
timeFrame: Early Termination before Week 4 (anytime between Week 1 to Week 4)
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Screening on Week 5
timeFrame: Screening before treatment started at Week 5
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Day 1 of Week 5
timeFrame: Day 1 of Week 5
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 6
timeFrame: Week 6
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 8
timeFrame: Week 8
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Week 10
timeFrame: Week 10
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) at Early Termination Before Week 10
timeFrame: Early Termination before Week 10 (anytime between Week 5 to Week 10)
measure: Apparent Oral Clearance (CL/F) of PF-06412528
timeFrame: Anytime post-dose on Visit 4 (Week 4)
measure: Average Concentration at Steady-state (Css, av) of PF-06412528
timeFrame: Anytime post-dose on Visit 4 (Week 4)
Secondary outcomes:
measure: Number of Participants With Pre-defined Criteria of Vital Signs
timeFrame: Week 1 up to Week 10
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Week 1 up to Week 10
measure: Apparent Volume of Distribution (Vz/F) of PF-06412528
timeFrame: Anytime post-dose on Visit 4 (Week 4)
measure: Dose-Exposure Relationship of Metabolites of Morphine, Naltrexone and 6-β-Naltrexol
timeFrame: Anytime post-dose on Visit 4 (Week 4)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Gottschalk Medical Plaza
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: The University of California, Irvine Health - Medical Specialties
state: California
city: Orange
country: United States
facility: UCI Medical Center- Outpatient Pharmacy
state: California
city: Orange
country: United States
facility: University of California, Irvine Health-Inpatient Pharmacy
state: California
city: Orange
country: United States
facility: University of California, Irvine Health-Medical Specialties
state: California
city: Miami Lakes
country: United States
facility: Veritas Research Corp.
state: Florida
city: Miami
country: United States
facility: Holtz Children Hospital/Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital - Pharmacy Department Basement West
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center-Alex's Place
state: Florida
city: Miami
country: United States
facility: University of Miami / Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago Clinical Research Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at the Med Center, University of Illinois
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Greenville
country: United States
facility: East Carolina University Brody School of Medicine(ECU)
state: North Carolina
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center Pharmacy Attn: Rebecca Turnage
state: North Carolina
city: Salt Lake City
country: United States
facility: Primary Children's Hospital Outpatient Services
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: