Tapentadol in Chronic Malignant Tumour Related Pain
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Frequency and severity of Adverse Events [ Time Frame: From date of first IMP intake until date of 3 days after last IMP intake, assessed up to 4 years ] [ Designated as safety issue: Yes ]
- Assess consumption of tapentadol during long term use [ Time Frame: From date of first IMP intake until date of last IMP intake, assessed up to 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Tapentadol Prolonged Release
Participants allocated to this treatment arm can be dosed between 100 to 250 mg tapentadol twice daily.
Drug: tapentadol prolonged release
Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.
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 prolonged release 100 mg to 250 mg twice daily.
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 Period.
This trial was designed to offer patients with chronic malignant tumor-related pain the option of continuing treatment by receiving tapentadol PR.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264887
|Shoumen, Bulgaria, 9700|
|Nyiregyhaza, Hungary, 4412|
|Szekszard, Hungary, 7100|
|Moldova, Republic of|
|Chisinau, Moldova, Republic of, 2025|
|Bydgoszcz, Poland, 85796|
|Warszawa, Poland, 02781|
|Brasov, Romania, 500074|
|Bucharest, Romania, 022328|
|Nizhniy Novgorod, Russian Federation, 603140|
|Vladikavkaz, Russian Federation, 362007|
|Nis, Serbia, 18000|
|Sremska Kamenica, Serbia, 21204|
|Principal Investigator:||Hans-Georg Kress, Prof. Dr. med||General Hospital Vienna|