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Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients

NCT02321319 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-05-21

Study results available
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Summary

This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic painful conditions who are "opioid-tolerant" prior to enrollment under the Pediatric Research Equity Act (PREA) of 2003.

Conditions

Interventions

DRUG

Hydromorphone HCl ER Tablets

Hydromorphone hydrochloride (HCl) extended release tablet

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Clinical Study Leader · Mallinckrodt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-11
Primary Completion
2019-02-04
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02321319 on ClinicalTrials.gov