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

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ClinicalTrials.gov Identifier: NCT02680847
Recruitment Status : Terminated (The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.)
First Posted : February 12, 2016
Results First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Moderate-severe Pain Drug: ALO-02 Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALO-02
One arm, open label, active
Drug: ALO-02
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.
Other Name: oxycodone hydrochloride/naltrexone hydrochloride




Primary Outcome Measures :
  1. Average Steady-state Concentration (Css, av) of Oxycodone [ Time Frame: 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 ]
    ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

  2. Apparent Oral Clearance (CL/F) of Oxycodone [ Time Frame: 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 ]
    ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

  3. Number of Participants With All-causality and Treatment-related Adverse Events (AEs) [ Time Frame: Baseline up to Day 63 ]
    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.

  4. Number of All-causality and Treatment-related AEs, by Intensity [ Time Frame: Baseline up to Day 63 ]
    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.

  5. Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 63 ]
    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.

  6. Number of Participants With Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: 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. ]
    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)


Secondary Outcome Measures :
  1. Apparent Volume of Distribution (Vz/F) of Oxycodone [ Time Frame: 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 ]
    ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.

  2. Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol. [ Time Frame: 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 ]
    Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.

  3. Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria [ Time Frame: Baseline up to Day 58 ]
    Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria. None of the vital sign changes were clinically significant.

  4. Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry) [ Time Frame: Baseline up to Day 77 ]
    Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680847


Locations
United States, California
Research Center For Clinical Studies-West, Inc.
Lancaster, California, United States, 93534
Children's Hopsital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, United States, 90027
Shriners Hospitals For Children Northern California
Sacramento, California, United States, 95817
UC Davis Health Attn: Peter Trovitch, PharmD
Sacramento, California, United States, 95817
University of California Davis
Sacramento, California, United States, 95817
United States, Illinois
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States, 60612
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, United States, 60612
University of Illinois Hospital at the Medical Center
Chicago, Illinois, United States, 60612
United States, North Carolina
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, United States, 27834
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, United States, 27834
United States, South Carolina
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, Investigational Drugs Services
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, United States, 29425
United States, Texas
Road Runner Research, Ltd
San Antonio, Texas, United States, 78249
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] July 6, 2006
Statistical Analysis Plan  [PDF] October 23, 2015


Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02680847     History of Changes
Other Study ID Numbers: B4531015
ALO-02 PHASE 4 PEDIATRIC STUDY ( Other Identifier: Alias Study Number )
First Posted: February 12, 2016    Key Record Dates
Results First Posted: September 25, 2018
Last Update Posted: September 25, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Pediatric
pain indication
controlled release oxycodone

Additional relevant MeSH terms:
Naltrexone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics