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NCT02221674 · ClinicalTrials.gov registry record · Phase 2
Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old
A Phase 2 study, sponsored by Grünenthal.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02221674: Clinical Trial Phase 2 study, sponsored by Grünenthal.
NCT02221674 is a Phase 2 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02221674, a Phase 2 study, was terminated before completion, sponsored by Grünenthal.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain. The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.
Primary Outcome
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages. Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points. Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated. Summary statistics at a given time p
Interventions
- DRUG Tapentadol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2016-11-03 |
| Phase | Phase 2 |
Why NCT02221674 stopped before completion
NCT02221674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Tapentadol is the first listed.
NCT02221674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02221674 about?
NCT02221674 is a clinical study titled "Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old". This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children ag...
What is the current status of trial NCT02221674?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2014-11-05. Estimated completion is 2016-11-03.
What interventions are being tested in trial NCT02221674?
The interventions under investigation include: Tapentadol (DRUG).
Who is sponsoring clinical trial NCT02221674?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02221674's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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