Clinical trial · Interventional
CORAL XT - Open-label Extension Trial of the CORAL Trial
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
NCT02031432CI-TRIAL-00052711CORAL XTcompletedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pain | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cebranopadol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cebranopadol
- description
- Cebranopadol 200 µg to 1000 µg per taken taken once a day in the morning. Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day.
- interventionNames
- Drug: Cebranopadol
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Event (TEAEs)
- timeFrame
- Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)
- description
- The safety of cebranopadol was assessed by the number of participants with treatment emergent adverse events (TEAEs). A TEAE was any adverse event that occurred after the first administration of investigational medicinal product (IMP), i.e., cebranopadol in this study. In addition, pretreatment adverse events which worsened during the treatment period were also considered TEAEs.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTKoch ED, Kapanadze S, Eerdekens MH, Kralidis G, Letal J, Sabatschus I, Ahmedzai SH. Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks. J Pain Symptom Manage. 2019 Sep;58(3):390-399. doi: 10.1016/j.jpainsymman.2019.05.012. Epub 2019 May 30. PMID 31152783