This treatment is intended to treat subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF5503/15 trial. MedDRA version: 14.0 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Tapentadol 50 mg prolonged-release tablet
Product Code: CG5503
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol hydrochloride
CAS Number: 175591-09-0
Current
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. 2. At least 18 years of age. 3. 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 (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Female subjects of child-bearing potential must have a negative pregnancy test at enrollment. 4. Within 24 weeks of either full completion or completion of the Double-blind Treatment Period (Visit 8) of KF5503/15 trial performed in subjects with moderate to severe chronic malignant tumor related pain. 5. Subject 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. 6. Subjects must be willing to take tapentadol PR throughout their participation in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of alcohol and/or drug abuse. 2. The subject has a clinically significant disease other than cancer that in the Investigator’s opinion may affect the safety of the subject (e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric [resulting in disorientation, memory impairment, or inability to report accurately], or metabolic disturbances). 3. Employees of the Investigator or trial center or family members of the employees or the Investigator. 4. Known to or suspected of not being able to comply with the protocol and the use of tapentadol PR (e.g., subjects not compliant with the use of Investigational Medicinal Product during the previous tapentadol PR trial). 5. 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. 6. Previous participation in another trial between the end of KF5503/15 and enrollment into the current trial, KF5503/52. 7. History of seizure disorder, epilepsy, or any of the following within 1 year: mild/moderate traumatic brain injury, stroke or transient ischemic attack. Severe traumatic brain injury within 15 years (consisting of at least 1 of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting for more than 24 hours). Severe traumatic brain injury with residual sequelae suggesting transient changes in consciousness. 8. Known history and/or presence of cerebral tumors or metastases. 9. As judged by the Investigator, the subject has rapidly escalating pain or pain uncontrolled by therapy and was previously treated with maximum (dose level 4) Investigational Medicinal Product dose. 10. Subjects taking any prohibited concomitant medications (as specified in “Prohibited concomitant treatments”). 11. Uncontrolled hypertension (repeated measurements of systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg). 12. Known moderate or severe hepatic impairment. 13. Known severe renal impairment. 14. Clinically relevant history of hypersensitivity, allergy, or contraindications to mu-opioid receptor agonists (e.g., paralytic ileus, acute or severe bronchial asthma or hypercapnia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The characterization of the long term safety profile of tapentadol PR at doses ranging from 100 mg to 250 mg taken twice daily, in patients with malignant tumor-related pain;Secondary Objective: To characterize tapentadol PR dose requirements during long-term consumption.;Primary end point(s): Number of subjects with Adverse Events as a measure of safety and tolerability.;Timepoint(s) of evaluation of this end point: From date of first IMP intake until date of 3 days after last IMP intake, assessed up to 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assess consumption of Tapentadol during long term use;Timepoint(s) of evaluation of this end point: From date of first IMP intake until date of last IMP intake, assessed up to 4 years | — |
Countries
Austria, Bulgaria, Croatia, Czech Republic, France, Hungary, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, Spain
Contacts
Public ContactClinical Development Operations
Grünenthal GmbH
Outcome results
None listed