Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

NCT02680847 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: B4531015ALO-02 PHASE 4 PEDIATRIC STUDY
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 16

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.

Conditions

Moderate-severe Pain

Keywords

Pediatric; pain indication; controlled release oxycodone

Outcome Measures

Primary Outcomes (6)

• Average Steady-state Concentration (Css, av) of Oxycodone

  ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

  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

• Apparent Oral Clearance (CL/F) of Oxycodone

  ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

  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

• Number of Participants With All-causality and Treatment-related Adverse Events (AEs)

  An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.

  Baseline up to Day 63

• Number of All-causality and Treatment-related AEs, by Intensity

  An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.

  Baseline up to Day 63

• Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)

  An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.

  Baseline up to Day 63

• Number of Participants With Clinical Opiate Withdrawal Scale (COWS)

  The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal. A subject assessed with a COWS score\>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (\<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (\>36)

  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 (4)

• Apparent Volume of Distribution (Vz/F) of Oxycodone

  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

• Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.

  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

• Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria

  Baseline up to Day 58

• Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)

  Baseline up to Day 77

Study Arms (1)

ALO-02

EXPERIMENTAL

One arm, open label, active

Drug: ALO-02

Interventions

ALO-02 DRUG

Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.

Also known as: oxycodone hydrochloride/naltrexone hydrochloride

ALO-02

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 \> 6 mg per day of oxycodone, 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

Research Center For Clinical Studies-West, Inc.

Lancaster, California, 93534, United States

Location

Children's Hopsital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine

Los Angeles, California, 90027, United States

Location

Shriners Hospitals For Children Northern California

Sacramento, California, 95817, United States

Location

UC Davis Health Attn: Peter Trovitch, PharmD

Sacramento, California, 95817, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University of Illinois at Chicago Clinical Research Center

Chicago, Illinois, 60612, United States

Location

University of Illinois Hospital and Health Sciences Systems

Chicago, Illinois, 60612, United States

Location

University of Illinois Hospital at the Medical Center

Chicago, Illinois, 60612, United States

Location

East Carolina University Brody School of Medicine(ECU)

Greenville, North Carolina, 27834, United States

Location

Leo Jenkins Cancer Center Pharmacy

Greenville, North Carolina, 27834, United States

Location

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina, Investigational Drugs Services

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina, Rutledge Tower, Pediatric Clinic

Charleston, South Carolina, 29425, United States

Location

Medical University of South Carolina, SCTR Research Nexus

Charleston, South Carolina, 29425, United States

Location

Road Runner Research, Ltd

San Antonio, Texas, 78249, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.
• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

oxycodone naltrexone combination; Oxycodone; Naltrexone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone

Limitations and Caveats

The study was terminated due to sponsor's decision instead of safety or efficacy reasons. Early termination led to small numbers of participants summarized or described and PK samples were not analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 12, 2016
• Study Start: January 21, 2016
• Primary Completion: January 10, 2018
• Study Completion: January 24, 2018
• Last Updated: September 25, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-08

Locations

US (16)