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

Phase 3CompletedNCT02031432

Tris Pharma, Inc.76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Neoplasms Chronic Pain

Interventions

CebranopadolDRUG

Film-coated tablet; strengths: 200, 400, or 600 µg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

AT004

Vienna, Austria

BE001

Sint-Niklaas, Belgium

BG001

Shumen, Bulgaria

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Event (TEAEs)

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.

Time frame: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)

Secondary Outcomes

Intensity of Treatment Emergent Adverse Events

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.

Time frame: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose)

Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period

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.

Time frame: Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks).

Data from ClinicalTrials.gov

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