Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
27 août 2018 mis à jour par: Pfizer
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
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
32
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Lancaster, California, États-Unis, 93534
- Research Center For Clinical Studies-West, Inc.
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Los Angeles, California, États-Unis, 90027
- Children's Hospital of Los Angeles - University of Southern California School of Medicine
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Los Angeles, California, États-Unis, 90027
- Children's Hopsital Los Angeles
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Sacramento, California, États-Unis, 95817
- University of California Davis
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Sacramento, California, États-Unis, 95817
- Shriners Hospitals For Children Northern California
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Sacramento, California, États-Unis, 95817
- UC Davis Health Attn: Peter Trovitch, PharmD
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Illinois
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Chicago, Illinois, États-Unis, 60612
- University of Illinois at Chicago Clinical Research Center
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Chicago, Illinois, États-Unis, 60612
- University of Illinois Hospital and Health Sciences Systems
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Chicago, Illinois, États-Unis, 60612
- University of Illinois Hospital at the Medical Center
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North Carolina
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Greenville, North Carolina, États-Unis, 27834
- Leo Jenkins Cancer Center Pharmacy
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Greenville, North Carolina, États-Unis, 27834
- East Carolina University Brody School of Medicine(ECU)
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina Children's Hospital
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina, SCTR Research Nexus
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina, Investigational Drugs Services
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Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
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Texas
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San Antonio, Texas, États-Unis, 78249
- Road Runner Research, Ltd
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
7 ans à 17 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: ALO-02
One arm, open label, active
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Average Steady-state Concentration (Css, av) of Oxycodone
Délai: 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.
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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
Délai: 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.
|
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)
Délai: 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.
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Baseline up to Day 63
|
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Number of All-causality and Treatment-related AEs, by Intensity
Délai: 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.
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Baseline up to Day 63
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Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
Délai: 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.
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Baseline up to Day 63
|
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Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
Délai: 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.
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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)
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Apparent Volume of Distribution (Vz/F) of Oxycodone
Délai: 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.
|
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
|
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Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
Délai: 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
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Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.
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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
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Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
Délai: Baseline up to Day 58
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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.
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Baseline up to Day 58
|
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Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
Délai: Baseline up to Day 77
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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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Baseline up to Day 77
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 janvier 2016
Achèvement primaire (Réel)
10 janvier 2018
Achèvement de l'étude (Réel)
24 janvier 2018
Dates d'inscription aux études
Première soumission
20 janvier 2016
Première soumission répondant aux critères de contrôle qualité
9 février 2016
Première publication (Estimation)
12 février 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 septembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 août 2018
Dernière vérification
1 août 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B4531015
- ALO-02 PHASE 4 PEDIATRIC STUDY (Autre identifiant: Alias Study Number)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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