Pain Clinical Trial
Official title:
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
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 were given either tapentadol or
morphine prolonged-release (PR) tablets. Assignment was done randomly (like tossing a coin).
The participant and the caregiver knew which medication the child was taking. The primary
endpoint was based on data collected in Part 1 of this study.
If eligible and willing, participants from Part 1 could enter a 12 month follow-up period
(Part 2). In Part 2 of this study, participants were either treated with tapentadol PR
tablets or entered observations arms where they were not treated at all or with standard of
care.
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