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NCT02081391 · ClinicalTrials.gov registry record · Phase 3
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
A Phase 3 study, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT02081391: Completed Phase 3 study, sponsored by Grünenthal.
NCT02081391 is a Phase 3 study that has completed, run by Grünenthal. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02081391, a Phase 3 study, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would produce moderate to severe pain during opioid treatment.
Primary Outcome
The primary endpoint for the United States Food and Drug Administration (US FDA) (and secondary endpoint for the Pediatric Committee of the European Medicines Agency \[EU PDCO\]) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to \<18 years old) within 12 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.
Interventions
- OTHER Placebo
- DRUG Tapentadol oral solution 4 mg/mL
- DRUG Tapentadol oral solution 20 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2015-02-19 |
| Est. Completion | 2019-03-14 |
| Phase | Phase 3 |
What the finished NCT02081391 record still lists
NCT02081391 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02081391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02081391 about?
NCT02081391 is a clinical study titled "A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain". The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product (IMP) in children and adolescents who had undergone surgery that would pr...
What is the current status of trial NCT02081391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2015-02-19. Estimated completion is 2019-03-14.
What interventions are being tested in trial NCT02081391?
The interventions under investigation include: Placebo (OTHER), Tapentadol oral solution 4 mg/mL (DRUG), Tapentadol oral solution 20 mg/mL (DRUG).
Who is sponsoring clinical trial NCT02081391?
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 NCT02081391's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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