Pain Clinical Trial
Official title:
Open-label, Single-arm, Flexible Dosing, Phase III Trial, With Oral Tapentadol Prolonged Release (PR) in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.
The purpose of this trial is the characterization of the long term safety profile and long-term dose requirements of tapentadol PR (prolonged release) in patients with malignant tumor-related pain. In the United States the prolonged-release formulation is also referred to as the extended-release formulation.
The prevalence of tumor-related pain is high and the treatment of chronic tumor-related pain
remains a challenging therapeutic problem.
Participants directly entering the KF5503/52 trial from the KF5503/15 trial (i.e., within 7
days of Visit 8 of the KF5503/15 trial) is scheduled: a Transfer Visit, an Open-label
Treatment Period and a Follow-up Period.
For participants with 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 the following is
scheduled: an Enrollment Visit, an Entry Visit for assessment of eligibility, an Open-label
Treatment Period and a Follow-up Period.
This trial was designed to offer patients with chronic malignant tumor-related pain the
option of continuing treatment by receiving tapentadol prolonged release (PR).
The protocol scheduled visits every 28 days during the open-label treatment period.
Unscheduled visits (or at least unscheduled telephone calls) were planned when dose
adjustment is required. If a visit is not possible at the time of dose change, it could be
done up to 7 days later. Unscheduled visits could also be performed whenever considered
necessary (i.e., for evaluation of adverse events).
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