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NCT01729728 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
A Phase 2 study, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT01729728: Completed Phase 2 study, sponsored by Grünenthal.
NCT01729728 is a Phase 2 study that has completed, run by Grünenthal. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01729728, a Phase 2 study, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose. Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating both acute and chronic pain in adults. This trial will help to understand how tapentadol oral solution works in children.
Primary Outcome
Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.
Interventions
- DRUG Tapentadol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2012-11 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT01729728 record still lists
NCT01729728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which Tapentadol is the first listed.
NCT01729728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01729728 about?
NCT01729728 is a clinical study titled "Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain". To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose. Tapentadol oral solution for children is still being tested and is not yet registered. Tapentadol tablets are effective in treating...
What is the current status of trial NCT01729728?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2012-11. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01729728?
The interventions under investigation include: Tapentadol (DRUG).
Who is sponsoring clinical trial NCT01729728?
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 NCT01729728's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 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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