None listed
Conditions
Interventions
Subjects will receive cebranopadol and the dose will be up- or down-titrated to reach the individual subjects’ optimal dose defined as a balance between self-reported analgesia and side effects during
g. The minimum daily dose will be cebranopadol 200 μ
g per day
the maximum daily dose will be cebranopadol 1000 μ
g per day.
Sponsors
GRUNENTHAL GmbH,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent signed indicating that the subject understands the purpose of and procedures required for the trial and is willing to participate in the trial. 2. Subjects must be at least 18 years of age at the Enrollment Visit 3. Women of childbearing potential must have a negative pregnancy test at Visit 1 and must not be lactating at Visit 1. 4. 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 <1% per year. For example: • Hormonal contraceptives for the duration of the trial and until for at least 4 weeks after Final Visit. • An intra-uterine device. Additional barrier contraception must be used by the partner for the duration of the trial. A double-barrier method should be supplemented by the use of spermicidal agents. Women of nonchildbearing potential may be included if surgically sterile (i.e., after hysterectomy) or post-menopausal for at least 2 years and ≥55 years old. For men:
Exclusion criteria
Exclusion criteria: 1. The subject has a clinically significant disease or condition 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, psychiatric (resulting in disorientation, memory impairment or inability to report accurately) or metabolic disorders or clinically relevant history of hypersensitivity, allergy or contraindications to opioid medication or any of the excipients of cebranopadol film-coated tablets. 2. Known to or suspected of not being able to comply with the protocol and the use of cebranopadol. 3. Subjects taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment (see Section 10.5). 4. History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia). 5. Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Denmark, France, Germany, Hungary, Mexico, New Zealand, Peru, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kindgdom
Contacts
Public ContactRosario Torres
GRUNENTHAL PERUANA S.A.
Outcome results
None listed