Last updated on October 2017

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.

Brief description of study

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).

Clinical Study Identifier: NCT02151682

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Erlangen, Germany
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Recruitment Status: Open

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