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NCT02508935 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
A Phase 4 study, sponsored by Mallinckrodt.
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT02508935: Clinical Trial Phase 4 study, sponsored by Mallinckrodt.
NCT02508935 is a Phase 4 study that was terminated before completion, run by Mallinckrodt. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508935, a Phase 4 study, was terminated before completion, sponsored by Mallinckrodt.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of XARTEMIS XR in this population.
Primary Outcome
The time to reach steady state in participants who received all 5 doses
Interventions
- DRUG XARTEMIS XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-11-20 |
| Est. Completion | 2017-04-26 |
| Phase | Phase 4 |
Why NCT02508935 stopped before completion
NCT02508935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which XARTEMIS XR is the first listed.
NCT02508935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02508935 about?
NCT02508935 is a clinical study titled "Pharmacokinetics (PK) and Safety Study of XARTEMIS® XR in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain". Phase 4, multicenter, open-label, multiple-dose study of the pharmacokinetics (PK) and safety of XARTEMIS XR in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain. The study will assess the safety of administering multiple doses of XARTEMIS XR in this population.
What is the current status of trial NCT02508935?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2015-11-20. Estimated completion is 2017-04-26.
What interventions are being tested in trial NCT02508935?
The interventions under investigation include: XARTEMIS XR (DRUG).
Who is sponsoring clinical trial NCT02508935?
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 NCT02508935's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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