Trials / Terminated
TerminatedNCT02321319
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
An Open-Label, Safety and Pharmacokinetic Study of Hydromorphone Hydrochloride Extended-Release Tablets (Once-Daily Hydromorphone) in Opioid-Tolerant Pediatric Subjects With Chronic Pain
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Mallinckrodt · Industry
- Sex
- All
- Age
- 7 Years – 17 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Hydromorphone HCl ER Tablets | Hydromorphone hydrochloride (HCl) extended release tablet |
Timeline
- Start date
- 2017-03-11
- Primary completion
- 2019-02-04
- Completion
- 2019-02-04
- First posted
- 2014-12-22
- Last updated
- 2020-05-21
- Results posted
- 2020-05-20
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02321319. Inclusion in this directory is not an endorsement.