Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol PR in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.
The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain
remains a challenging therapeutic problem.
This is a clinical trial with only 1 treatment group: tapentadol ER 100 mg to 250 mg twice
For subjects who have directly entered the KF5503/52 trial from the KF5503/15 trial (i.e.,
within 7 days of Visit 8 of the KF5503/15 trial): a Transfer Visit, an Open-label Treatment
Period and a Follow-up Period.
For subjects who have a gap of more than 7 days and less than 24 weeks, between their full
completion of the KF5503/15 trial and entry into the KF5503/52 trial: an Enrollment Visit,
an Entry Visit for assessment of eligibility, an Open-label Treatment Period and a Follow-up
This trial was designed to offer patients with chronic malignant tumor-related pain the
option of continuing treatment by receiving tapentadol PR.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of subjects with Adverse Events as a measure of safety and tolerability
From date of first IMP intake until date of 3 days after last IMP intake, assessed up to 4 years
Hans-Georg Kress, Prof. Dr. med
General Hospital Vienna
Austria: Agency for Health and Food Safety