Recruitment

Recruitment Status
Completed
Estimated Enrollment
200

Inclusion Criteria

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.
Participant does not meet any of the compulsory discontinuation criteria.
Participant is still in need of prolonged release opioid treatment.

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 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.
Participant does not meet any of the compulsory discontinuation criteria.
Participant is still in need of prolonged release opioid treatment.

Locations

Porto, 4200-319
Homburg, 66421
Manchester, M13 9WL
Sofia, 1606
Valladolid, 47005
...
Porto, 4200-319
Homburg, 66421
Manchester, M13 9WL
Sofia, 1606
Valladolid, 47005
Santiago, 7500996
Turin, 10126
Amiens, 80054
Sofia, 1606
Plovdiv, 4001
Sheffield, S10 2TH
Budapest, 1094
Vandoeuvre les Nancy, 54500
Villejuif Cedex, 94805
Lille, 59020
Leuven, 3000
Brest, 29609
Lyon, 69008
Leeds, LS1 3EX
Valparaíso, 2341131
Pleven, 5800
Braga, 4710-243
Nice, 06200

Tracking Information

NCT #
NCT02151682
Collaborators
Not Provided
Investigators
Study Director: Director Clinical Trials Grünenthal GmbH