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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 is a Phase 2 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 40 participants.
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.
Interventions
- DRUG Tapentadol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2016-11-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02221674
The ClinicalTrials.gov registry entry for NCT02221674 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grünenthal, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tapentadol is the first listed.
NCT02221674 reports 0 study locations.
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.
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