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

Tris Pharma

Status and phase: Completed; Phase 3

Conditions: Neoplasms; Chronic Pain; Pain

Treatments: Drug: Cebranopadol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02031432

U1111-1144-0778 (Other Identifier)

KF6005/09

2013-001877-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Cebranopadol

Experimental group

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.

Treatment:

Drug: Cebranopadol