A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 200
Inclusion Criteria
- Participant does not meet any of the compulsory discontinuation criteria.
- Participant is still in need of prolonged release opioid treatment.
- Participant has completed the 14-day Treatment Period.
- Participant does not meet any of the compulsory discontinuation criteria.
- Participant is still in need of prolonged release opioid treatment.
- Participant has completed the 14-day Treatment Period.
Summary
- Conditions
- Pain
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Intervention Model Description: There were 2 arms in Part 1: Randomization was carried out in blocks and in a 2:1 ratio (tapentadol PR to morphine PR). Participants were stratified using interactive response technology: by age group (6 years to less than 12 years and 12 years to less than 18 years, at the second visit [Allocation Visit]) so that at least 25% of participants were in the younger age group, and by underlying pain condition (cancer/non-cancer-related pain). There were 4 arms in Part 2: The investigators/participants decided if participants from Part 1 switched to or continued on tapentadol PR (tapentadol arm) or if they received no treatment/standard of care treatment if needed (2 direct observation arms following treatment in Part 1 and 1 observation arm after initial treatment with tapentadol in Part 2).Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 6 years and 17 years
- Gender
- Both males and females
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 da...
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.
Inclusion Criteria
- Participant does not meet any of the compulsory discontinuation criteria.
- Participant is still in need of prolonged release opioid treatment.
- Participant has completed the 14-day Treatment Period.
- Participant does not meet any of the compulsory discontinuation criteria.
- Participant is still in need of prolonged release opioid treatment.
- Participant has completed the 14-day Treatment Period.
Tracking Information
- NCT #
- NCT02151682
- Collaborators
- Not Provided
- Investigators
- Study Director: Director Clinical Trials Grünenthal GmbH
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