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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 is a Phase 3 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02321319
The ClinicalTrials.gov registry entry for NCT02321319 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone HCl ER Tablets is the first listed.
NCT02321319 reports 0 study locations.
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.
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