An open-label, multi-site trial to describe the safety and tolerability of oral cebranopadol administered for 26 weeks in subjects with cancer-related pain who have completed treatment in the KF6005/07 trial - CORAL XT – Open-label extension trial of the CORAL trial

Grünenthal GmbH0 个研究点目标入组 220 人开始时间: 2014年9月2日最近更新: 2016年6月27日

研究概览

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•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.
•Subjects must be at least 18 years of age at the Enrollment Visit (Visit 1).
•Women of childbearing potential must have a negative pregnancy test at Visit 1 and must not be lactating at Visit 1.
•Subjects must be willing to use medically acceptable and highly effective methods of birth control.
•Subjects who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.
•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 128
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 92

•The subject has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
•Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
•Subjects taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
•History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., The subject has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
•Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
•Subjects taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
•History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
•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.
•Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.

发起方