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NCT01134536 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01134536 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 45 participants.
The verdict
NCT01134536, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
Interventions
- DRUG Tapentadol (OS) Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01134536
The ClinicalTrials.gov registry entry for NCT01134536 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tapentadol (OS) Oral Solution is the first listed.
NCT01134536 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01134536 about?
NCT01134536 is a clinical study titled "Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents". The purpose of this study is to evaluate the pharmacokinetic (PK) profile; and safety and tolerability of a single dose of tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from 6 to less than 18 years with acute, moderate to severe postsurgical pain.
What is the current status of trial NCT01134536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2011-10. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01134536?
The interventions under investigation include: Tapentadol (OS) Oral Solution (DRUG).
Who is sponsoring clinical trial NCT01134536?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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