Conditions: Pain Neoplasms Chronic Pain
Keywords: cancer-related pain cebranopadol
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 76
Healthy volunteers: no

Brief summary:
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.

Detailed description:
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.

Arms:
arm 1: Cebranopadol 200 µg to 1000 µg per taken taken once a day in the morning.

Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day.

Interventions: intervention 1: Cebranopadol
Intervention descriptions: intervention 1: Film-coated tablet; strengths: 200, 400, or 600 µg

Protocol document: