Phase 3
Completed N=76
CORAL XT - Open-label Extension Trial of the CORAL Trial
Postoperative Pain · Neoplasms
Source: ClinicalTrials.gov NCT02031432 ↗
Enrolled (actual)
76
Serious AEs
42.1%
Results posted
Jan 2020
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Event (TEAEs) — 64 Participants
◆ Published Evidence
Established
32citations · ~5 / year
Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks.
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.
Linked Publications
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Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Event (TEAEs) |
64 | — |
| SECONDARY Intensity of Treatment Emergent Adverse Events |
242; 300; 119 | — |
| SECONDARY Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period |
0.8 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02031432) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.