Back to resultsTapentadol in Chronic Malignant Tumour Related Pain
Primary Purpose
Cancer, Chronic Pain, Pain
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tapentadol Prolonged Release
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring analgesia, analgesics, chronic pain, tumour related pain, chronic malignant tumor-related pain
Eligibility Criteria
Inclusion Criteria:
- Participants must have signed an Informed Consent Form.
- At least 18 years of age.
- Male and non-pregnant, non-lactating female subjects. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the trial. Female participants of child-bearing potential must have a negative pregnancy test at enrollment.
- Within 24 weeks of either full completion or completion of the double-blind treatment period (Visit 8) of KF5503/15 trial performed in participants with moderate to severe chronic malignant tumor related pain.
- Participant is, in the opinion of the investigator, expected to continue to have an overall positive benefit/risk ratio from continuing analgesic treatment within this trial.
- Participant must be willing to take tapentadol prolonged release (PR) throughout their participation in the trial.
Exclusion Criteria:
- History of alcohol and/or drug abuse.
- The participant has a clinically significant disease other than cancer that in the Investigator's opinion may affect the safety of the participant.
- Employees of the investigator or trial center or family members of the employees or the investigator.
- Known to or suspected of not being able to comply with the protocol and the use of tapentadol prolonged release (PR).
- Concurrent participation in another trial (except for participation in the KF5503/15 trial) or planning to be enrolled in another clinical trial during the course of this trial.
- Previous participation in another trial between the end of KF5503/15 and enrollment into the current trial, KF5503/52.
- History of seizure disorder, epilepsy, traumatic brain injury, stroke or transient ischemic attack.
- Known history and/or presence of cerebral tumors or metastases.
- Rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum dose level of Investigational Medicinal Product.
- Participant is taking any prohibited concomitant medications.
- Uncontrolled hypertension.
- Known moderate or severe hepatic impairment.
- Known severe renal impairment.
- Clinically relevant history of hypersensitivity, allergy, or contraindications to tapentadol or its excipients.
Sites / Locations
- Site 359004
- Site 036002
- Site 036010
- Site 373001
- Site 048004
- Site 048001
- Site 040006
- Site 040002
- Site 007007
- Site 007012
- Site 381002
- Site 381001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tapentadol Prolonged Release
Arm Description
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).
Outcomes
Primary Outcome Measures
Severity of Adverse Events
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
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
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
The onset and duration of TEAEs was not evaluated for this trial.
Secondary Outcome Measures
Assess Consumption of Tapentadol During Long Term Use
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01264887
Brief Title
Tapentadol in Chronic Malignant Tumour Related Pain
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Chronic Pain, Pain
Keywords
analgesia, analgesics, chronic pain, tumour related pain, chronic malignant tumor-related pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapentadol Prolonged Release
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Tapentadol Prolonged Release
Other Intervention Name(s)
Nucynta®, Palexia®, Yantil®
Intervention Description
Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.
Primary Outcome Measure Information:
Title
Severity of Adverse Events
Description
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.
Time Frame
Day 1; up to 144 weeks
Title
Relatedness Assessment of Treatment Emergent Adverse Events
Description
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".
Time Frame
Day 1; up to 144 weeks
Title
Countermeasures Taken Due to Treatment Emergent Adverse Events
Description
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 Frame
Day 1; up to 144 weeks
Title
Time Dependence of Adverse Events
Description
The onset and duration of TEAEs was not evaluated for this trial.
Time Frame
Day 1; 144 weeks
Secondary Outcome Measure Information:
Title
Assess Consumption of Tapentadol During Long Term Use
Description
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.
Time Frame
Day 1; up to 144 weeks
Title
Tapentadol Prolonged Release Exposure
Description
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).
Time Frame
Day 1; up to 144 weeks
Other Pre-specified Outcome Measures:
Title
Average Pain Intensity (Over a Twelve-week Period)
Description
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.
Time Frame
Day 1; up to Week 144
Title
Average Daily Total Tapentadol Prolonged Release Dose
Description
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.
Time Frame
Day 1; up to 144 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have signed an Informed Consent Form.
At least 18 years of age.
Male and non-pregnant, non-lactating female subjects. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the trial. Female participants of child-bearing potential must have a negative pregnancy test at enrollment.
Within 24 weeks of either full completion or completion of the double-blind treatment period (Visit 8) of KF5503/15 trial performed in participants with moderate to severe chronic malignant tumor related pain.
Participant is, in the opinion of the investigator, expected to continue to have an overall positive benefit/risk ratio from continuing analgesic treatment within this trial.
Participant must be willing to take tapentadol prolonged release (PR) throughout their participation in the trial.
Exclusion Criteria:
History of alcohol and/or drug abuse.
The participant has a clinically significant disease other than cancer that in the Investigator's opinion may affect the safety of the participant.
Employees of the investigator or trial center or family members of the employees or the investigator.
Known to or suspected of not being able to comply with the protocol and the use of tapentadol prolonged release (PR).
Concurrent participation in another trial (except for participation in the KF5503/15 trial) or planning to be enrolled in another clinical trial during the course of this trial.
Previous participation in another trial between the end of KF5503/15 and enrollment into the current trial, KF5503/52.
History of seizure disorder, epilepsy, traumatic brain injury, stroke or transient ischemic attack.
Known history and/or presence of cerebral tumors or metastases.
Rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum dose level of Investigational Medicinal Product.
Participant is taking any prohibited concomitant medications.
Uncontrolled hypertension.
Known moderate or severe hepatic impairment.
Known severe renal impairment.
Clinically relevant history of hypersensitivity, allergy, or contraindications to tapentadol or its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Georg Kress, Prof. Dr. med
Organizational Affiliation
General Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site 359004
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Facility Name
Site 036002
City
Nyiregyhaza
ZIP/Postal Code
4412
Country
Hungary
Facility Name
Site 036010
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Site 373001
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Facility Name
Site 048004
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
Facility Name
Site 048001
City
Warszawa
ZIP/Postal Code
02781
Country
Poland
Facility Name
Site 040006
City
Brasov
ZIP/Postal Code
500074
Country
Romania
Facility Name
Site 040002
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site 007007
City
Nizhniy Novgorod
ZIP/Postal Code
603140
Country
Russian Federation
Facility Name
Site 007012
City
Vladikavkaz
ZIP/Postal Code
362007
Country
Russian Federation
Facility Name
Site 381002
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Site 381001
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
12. IPD Sharing Statement
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Tapentadol in Chronic Malignant Tumour Related Pain
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