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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 is a Phase 3 study that has completed, run by Grünenthal. The registered enrollment target is 216 participants.

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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.

Interventions

  • OTHER Placebo
  • DRUG Tapentadol oral solution 4 mg/mL
  • DRUG Tapentadol oral solution 20 mg/mL

Trial Details

FieldValue
Enrollment Target 216 participants
Start Date 2015-02-19
Est. Completion 2019-03-14
Phase Phase 3

Sponsor

Grünenthal

16 total trials

What the Registry Record Tells You About NCT02081391

The ClinicalTrials.gov registry entry for NCT02081391 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 216 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 3 interventions - of which Placebo is the first listed.

NCT02081391 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.