Clinical Trials/NCT02321319

NCT02321319

Terminated

Phase 3

An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain

Mallinckrodt3 sites in 1 country5 target enrollmentMarch 11, 2017

ConditionsChronic Pain

InterventionsHydromorphone HCl ER Tablets

DrugsHydromorphone HCl ER Tablets

Overview

Phase: Phase 3
Intervention: Hydromorphone HCl ER Tablets
Conditions: Chronic Pain
Sponsor: Mallinckrodt
Enrollment: 5
Locations: 3
Primary Endpoint: Number of Participants With Adverse Events (AEs)
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 11, 2017

End Date

February 4, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Hydromorphone HCl ER Tablets

Participants receive Hydromorphone HCl ER Tablets (4-16 mg, based on standard conversion ratios for common opioids)

Intervention: Hydromorphone HCl ER Tablets

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

Time Frame: 28 days

Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs

Study Sites (3)

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