A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain

NCT02151682 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-09-12

Study results available
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Summary

Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.

Conditions

Interventions

DRUG

Tapentadol prolonged release

DRUG

Morphine prolonged release

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Director Clinical Trials · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-29
Primary Completion
2017-10-18
Completion
2018-10-15

Countries

  • Belgium
  • Bulgaria
  • Chile
  • France
  • Germany
  • Hungary
  • Italy
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02151682 on ClinicalTrials.gov