CORAL XT - Open-label Extension Trial of the CORAL Trial
- Registration Number
- NCT02031432
- Lead Sponsor
- Tris Pharma, Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cebranopadol Cebranopadol 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Event (TEAEs) Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose) 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 Outcome Measures
Name Time Method Intensity of Treatment Emergent Adverse Events Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose) A Treatment Emergent Adverse Event (TEAE) was defined as any Adverse Event (AE) that occurred on or after the first intake of cebranopadol or a pretreatment AE which worsened during the treatment period. TEAEs were classified by the investigator as falling into 1 of 3 categories:
Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the participant is distracted.
Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.
Severe: Symptoms which affect usual daily activity.
For TEAE where the intensity changed over time, the maximum intensity observed during the whole duration of the adverse event was documented.Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks). Participants were asked "Please rate your pain by selecting the one number that best describes your pain on average during the last week." and scored their average pain intensity during the last week of the treatment period on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The absolute change from baseline for the average pain intensity during the last week was determined for all participants that scored their pain intensities. A mean value for all participants was calculated.
Trial Locations
- Locations (22)
BG008
🇧🇬Sofia, Bulgaria
BE001
🇧🇪Sint-Niklaas, Belgium
BG001
🇧🇬Shumen, Bulgaria
BG004
🇧🇬Sofia, Bulgaria
DK004
🇩🇰Herlev, Denmark
BG003
🇧🇬Sofia, Bulgaria
DK006
🇩🇰Aalborg, Denmark
AT004
🇦🇹Vienna, Austria
DE008
🇩🇪Böhlen, Germany
HU011
🇭🇺Nyiregyhaza, Hungary
DE010
🇩🇪Munich, Germany
PL012
🇵🇱Będzin, Poland
PL014
🇵🇱Dąbrowa Górnicza, Poland
PL010
🇵🇱Gliwice, Poland
RO002
🇷🇴Cluj-Napoca, Romania
RS003
🇷🇸Belgrade, Serbia
RS002
🇷🇸Sremska Kamenica, Serbia
RS005
🇷🇸Zrenjanin, Serbia
SK004
🇸🇰Bratislava, Slovakia
SK001
🇸🇰Presov, Slovakia
PL003
🇵🇱Gdansk, Poland
SK005
🇸🇰Pruské, Slovakia