Clinical trial NCT01264887: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cancer
Chronic Pain
Pain
Keywords: analgesia
analgesics
chronic pain
tumour related pain
chronic malignant tumor-related pain
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2010-12-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Severity of Adverse Events
timeFrame: Day 1; up to 144 weeks
measure: Relatedness Assessment of Treatment Emergent Adverse Events
timeFrame: Day 1; up to 144 weeks
measure: Countermeasures Taken Due to Treatment Emergent Adverse Events
timeFrame: Day 1; up to 144 weeks
measure: Time Dependence of Adverse Events
timeFrame: Day 1; 144 weeks
Secondary outcomes:
measure: Assess Consumption of Tapentadol During Long Term Use
timeFrame: Day 1; up to 144 weeks
measure: Tapentadol Prolonged Release Exposure
timeFrame: Day 1; up to 144 weeks
Other outcomes:
measure: Average Pain Intensity (Over a Twelve-week Period)
timeFrame: Day 1; up to Week 144
measure: Average Daily Total Tapentadol Prolonged Release Dose
timeFrame: Day 1; up to 144 weeks
Locations:
city: Shumen
country: Bulgaria
facility: Site 359004
city: Nyiregyhaza
country: Hungary
facility: Site 036002
city: Szekszard
country: Hungary
facility: Site 036010
city: Chisinau
country: Moldova, Republic of
facility: Site 373001
city: Bydgoszcz
country: Poland
facility: Site 048004
city: Warszawa
country: Poland
facility: Site 048001
city: Brasov
country: Romania
facility: Site 040006
city: Bucharest
country: Romania
facility: Site 040002
city: Nizhniy Novgorod
country: Russian Federation
facility: Site 007007
city: Vladikavkaz
country: Russian Federation
facility: Site 007012
city: Nis
country: Serbia
facility: Site 381002
city: Sremska Kamenica
country: Serbia
facility: Site 381001
Study officials:
affiliation: General Hospital Vienna
name: Hans-Georg Kress, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References: