Tapentadol in Chronic Malignant Tumour Related Pain
|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 Prolonged Release (PR) in Subjects With Chronic Malignant Tumor-related Pain Who Have Completed the Maintenance Period of the KF5503/15 Trial.|
- Severity of Adverse Events [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: Yes ]
The severity of treatment emergent adverse events was any untoward medical occurrence in a patient administered tapentadol. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the (investigational) medicinal product whether or not related to the use of tapentadol.
The clinical "intensity" of adverse event were classified as:
Mild: signs and symptoms which can be easily tolerated. Symptoms could be ignored and disappeared when the participant is distracted.
Moderate: symptoms caused discomfort but were tolerable, they could not be ignored and affect concentration.
Severe: symptoms affected the usual daily activity.
- Relatedness Assessment of Treatment Emergent Adverse Events [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: Yes ]Participant-based analysis of treatment emergent adverse events (TEAEs) regarding the relationship to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The relationship was rated by the investigator. The categorization of relatedness into one of the two categories was based on the following: Related included "possible", "probable/likely", and "certain"; whilst unrelated treatment emergent adverse events include those rated by the investigator as "unlikely", "conditional/unclassified", "un-assessable/unclassifiable", and "not related".
- Countermeasures Taken Due to Treatment Emergent Adverse Events [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: Yes ]Participant-based analysis of treatment emergent adverse events (TEAEs) regarding countermeasure to the study drug (tapentadol). The TEAEs were reported by the participants or were captured by the investigator. The countermeasure taken by the investigator were reported.
- Time Dependence of Adverse Events [ Time Frame: Day 1; 144 weeks ] [ Designated as safety issue: Yes ]The onset and duration of TEAEs was not evaluated for this trial.
- Assess Consumption of Tapentadol During Long Term Use [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: Yes ]Summary of the modal total daily dose during the treatment period. The modal dose was based on assessment of the consecutive morning and evening intake amounts on each day and evaluation of the total daily dose.
- Tapentadol Prolonged Release Exposure [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: No ]The number of days that participants took tapentadol prolonged release. The extent of exposure was categorized into 2 periods, less than 90 days and more than 90 days (up to 144 weeks).
- Average Pain Intensity (Over a Twelve-week Period) [ Time Frame: Day 1; up to Week 144 ] [ Designated as safety issue: No ]
The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Average pain intensity score is the average of pain experienced for previous 24 hours as rated on an 11-point NRS at each visit. Calculations are based on 3 consecutive planned (at 4-weekly intervals) visits.
All available data of a participant was used; if a participant dropped-out or had incomplete data during a 12-week period no imputations were performed for the missing values.
- Average Daily Total Tapentadol Prolonged Release Dose [ Time Frame: Day 1; up to 144 weeks ] [ Designated as safety issue: No ]The Total Daily Dose (TDD) on any given day is the sum of the morning and evening intake amounts. The average TDD is an individuals average over the trial period.
|Study Start Date:||March 2011|
|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 flexibly dosed between 100 to 250 mg tapentadol twice daily (50 and 100 mg tablets to be dispensed).
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.
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).
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|