CORAL XT - Open-label Extension Trial of the CORAL Trial

• Status: Completed
• Trial end date: 2016-05-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grünenthal GmbH; Tris Pharma, Inc.

Criteria

Inclusion Criteria:

• Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.

• Participants must be at least 18 years of age at the Enrollment Visit.

• Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.

• Participants must be willing to use medically acceptable and highly effective methods of birth control.

• Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.

Exclusion Criteria:

• The participant 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.

• Participants 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.