Clinical trial NCT02680847: Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Moderate-severe Pain
Keywords: Pediatric
pain indication
controlled release oxycodone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-12
Enrollment: 32
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 oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

Detailed description: This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain. The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks. The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period 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 \> 6 mg per day of oxycodone, 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: Average Steady-state Concentration (Css, av) of Oxycodone
timeFrame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
measure: Apparent Oral Clearance (CL/F) of Oxycodone
timeFrame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
measure: Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
timeFrame: Baseline up to Day 63
measure: Number of All-causality and Treatment-related AEs, by Intensity
timeFrame: Baseline up to Day 63
measure: Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 63
measure: Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
timeFrame: Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
Secondary outcomes:
measure: Apparent Volume of Distribution (Vz/F) of Oxycodone
timeFrame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
measure: Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
timeFrame: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
measure: Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
timeFrame: Baseline up to Day 58
measure: Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
timeFrame: Baseline up to Day 77
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Research Center For Clinical Studies-West, Inc.
state: California
city: Los Angeles
country: United States
facility: Children's Hopsital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
state: California
city: Sacramento
country: United States
facility: Shriners Hospitals For Children Northern California
state: California
city: Sacramento
country: United States
facility: UC Davis Health Attn: Peter Trovitch, PharmD
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
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 Hospital and Health Sciences Systems
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital at the Medical Center
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
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina Children's Hospital
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, Investigational Drugs Services
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina, SCTR Research Nexus
state: South Carolina
city: San Antonio
country: United States
facility: Road Runner Research, Ltd
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: