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

Phase 3

Terminated

• Conditions: Chronic Pain
• Interventions: Drug: Hydromorphone HCl ER Tablets

• Registration Number: NCT02321319
• Lead Sponsor: Mallinckrodt

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Study Start: 2017-03-11
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Status Verified: 2020-05
• Results First Submitted: 2020-05-05
• Results First Submitted QC: 2020-05-05
• Results First Posted: 2020-05-20
• Last Update Submitted: 2020-05-20
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	28 days	Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs

Trial Locations

Locations (3)

Jackson Memorial Hospital, University of Miami; 🇺🇸 Miami, Florida, United States

Clinical Pharmacology Services, Inc.; 🇺🇸 Tampa, Florida, United States

Medical Professional Clinical Research; 🇺🇸 Miami, Florida, United States