An Open-label Trial Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR Followed by an Open-label Extension.

  • STATUS
    Not Recruiting
  • participants needed
    200
  • sponsor
    Grünenthal GmbH
Updated on 23 January 2021
DE002 (8.7 mi away) Contact
morphine
opioid
cancer
tapentadol

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. During the first 2 weeks of the study (Part 1), participants will be given either tapentadol or morphine prolonged-release tablets. Assignment will be done randomly (like tossing a coin). The participant and the caregiver will know which medication they are taking. The primary endpoint is based on data collected in Part 1 of this trial. If eligible and willing, participants from Part 1 can enter a 12 month follow-up period (Part 2). In Part 2 of this trial participants will be treated with tapentadol prolonged release tablets or with the standard of care (observation arm).

Details
Condition Pain, Acute Pain Service
Treatment Tapentadol prolonged release, Morphine prolonged release
Clinical Study IdentifierNCT02151682
SponsorGrünenthal GmbH
Last Modified on23 January 2021

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