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NCT02321319 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
A Phase 3 study, sponsored by Mallinckrodt.
- Terminated
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
NCT02321319: Clinical Trial Phase 3 study, sponsored by Mallinckrodt.
NCT02321319 is a Phase 3 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02321319, a Phase 3 study, was terminated before completion, sponsored by Mallinckrodt.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Clinically significant changes in vital signs, pulse oximetry, and/or clinical laboratory assessments, were recorded as AEs
Interventions
- DRUG Hydromorphone HCl ER Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-03-11 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 3 |
Why NCT02321319 stopped before completion
NCT02321319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone HCl ER Tablets is the first listed.
NCT02321319 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02321319 about?
NCT02321319 is a clinical study titled "Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients". 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 P...
What is the current status of trial NCT02321319?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2017-03-11. Estimated completion is 2019-02-04.
What interventions are being tested in trial NCT02321319?
The interventions under investigation include: Hydromorphone HCl ER Tablets (DRUG).
Who is sponsoring clinical trial NCT02321319?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02321319's enrollment target sits among peer trials
5 1997th of 2000 higher than 3 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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