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

NCT ID: NCT02031432

Last Updated: 2021-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-18
• Study Completion Date: 2016-05-03

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.

Conditions

Pain; Neoplasms; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cebranopadol

Intervention Type: DRUG

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

Interventions

Cebranopadol

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

Intervention Type: DRUG

Other Intervention Names

GRT6005

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tris Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Director Clinical Trials

Role: STUDY_DIRECTOR

Grünenthal GmbH

Locations

AT004

Vienna, , Austria

BE001

Sint-Niklaas, , Belgium

BG001

Shumen, , Bulgaria

BG008

Sofia, , Bulgaria

BG003

Sofia, , Bulgaria

BG004

Sofia, , Bulgaria

DK006

Aalborg, , Denmark

DK004

Herlev, , Denmark

DE008

Böhlen, , Germany

DE010

Munich, , Germany

HU011

Nyíregyháza, , Hungary

PL012

Będzin, , Poland

PL014

Dąbrowa Górnicza, , Poland

PL003

Gdansk, , Poland

PL010

Gliwice, , Poland

RO002

Cluj-Napoca, , Romania

RS003

Belgrade, , Serbia

RS002

Kamenitz, , Serbia

RS005

Zrenjanin, , Serbia

SK004

Bratislava, , Slovakia

SK001

Prešov, , Slovakia

SK005

Pruské, , Slovakia

Countries

Austria; Belgium; Bulgaria; Denmark; Germany; Hungary; Poland; Romania; Serbia; Slovakia

References

Koch 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.

Reference Type: RESULT

PMID: 31152783 (View on PubMed)

Other Identifiers

2013-001877-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1144-0778

Identifier Type: OTHER

Identifier Source: secondary_id

KF6005/09

Identifier Type: -

Identifier Source: org_study_id