CORAL XT - Open-label Extension Trial of the CORAL Trial
CompletedPhase 3NCT02031432
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Pain
- Neoplasms
- Chronic Pain
- Interventions
- Sponsor
- Tris Pharma, Inc.
- Start date
- 2013-12-18
- Primary completion
- 2016-04
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Austria, Belgium, Bulgaria, Denmark, Germany, Hungary, Poland, Romania, Serbia, Slovakia
- Total sites listed
- 22
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02031432