NCT02151682

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

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: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Tapentadol prolonged release
DRUG	Morphine prolonged release

Timeline

• Start date: 2015-04-29
• Primary completion: 2017-10-18
• Completion: 2018-10-15
• First posted: 2014-05-30
• Last updated: 2019-09-12
• Results posted: 2019-09-12

Locations

23 sites across 10 countries: Belgium, Bulgaria, Chile, France, Germany, Hungary, Italy, Portugal, Spain, United Kingdom