Pijn bij kanker pain related to cancer
Conditions
Interventions
Subjects who comply with all inclusion criteria and do not meet any of the
exclusion criteria will be randomly assigned to one of the 2 treatment arms
(Cebranopadol versus Morphine sulfate PR) in th
Sponsors
Grunenthal
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. 2. Subjects must be at least 18 years of age at the Enrollment Visit (Visit 1). 3. Women of childbearing potential must have a negative pregnancy test at Visit 1 and Visit 2 and must not be lactating at Visit 1. Subjects must be willing to use medically acceptable and highly effective methods of birth control. For women of childbearing potential a medically acceptable and highly effective method of birth control is defined as any form of contraception with a low failure rate defined as
Exclusion criteria
Exclusion criteria: 1. Evidence of ongoing alcohol/drug abuse or history of alcohol/drug abuse within the last 2 years in the investigator*s judgment, based on patient history and physical examination. 2. The subject has a clinically significant disease other than cancer which in the investigator's opinion may affect efficacy or safety assessments e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious disease, psychiatric (resulting in disorientation, memory impairment or inability to report accurately) or metabolic disorders. 3. Subjects with any gastrointestinal disorder that could, in the investigator*s opinion, affect the absorption and/or elimination of IMP. 4. Any pre-scheduled major surgery during the trial. 5. Known to or suspected of not being able to comply with the trial protocol and the use of IMP. 6. History of seizure disorder and/or epilepsy or any condition associated with a significant risk of seizure or epilepsy. 7. Known history and/or presence of cerebral tumor or cerebral metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the Maintenance Phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint is the proportion of subjects with clinically relevant pain reduction over the last 2 weeks of the Maintenance Phase. Definition of clinically relevant pain reduction: * Average pain intensity of | — |
Countries
Netherlands
Outcome results
None listed