not applicable

• Register: EUCTR
• Last refreshed on: 4 July 2016
• Main ID: EUCTR2013-001877-26-HU
• Date of registration: 06/09/2013
• Prospective Registration: Yes
• Primary sponsor: Grünenthal GmbH
• Public title: not applicable
• Scientific title: An open-label, multi-site trial to describe the safety and tolerability of oral cebranopadol administered for 26 weeks in subjects with cancer-related pain who have completed treatment in the KF6005/07 trial - CORAL XT – Open-label extension trial of the CORAL trial
• Date of first enrolment: 30/10/2013
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001877-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: yes Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Denmark, France, Germany, Hungary, Mexico, Netherlands, Peru, Poland, Romania, Serbia, Slovakia, Spain, Sweden, United Kingdom

Contacts

• Name: GRT Trial Information Desk
• Affiliation: Grünenthal GmbH

• Name: GRT Trial Information Desk
• Affiliation: Grünenthal GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Informed consent signed indicating that the subject understands the purpose of and procedures required for the trial and is willing to participate in the trial.
Subjects must be at least 18 years of age at the Enrollment Visit (Visit 1).
Women of childbearing potential must have a negative pregnancy test at Visit 1 and must not be lactating at Visit 1.
Subjects must be willing to use medically acceptable and highly effective methods of birth control.
Subjects who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 92

Exclusion criteria:
The subject 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.
Subjects 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., The subject 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.
Subjects 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 (this does not include observational studies), or previous participation in this trial. Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

cancer-related pain
MedDRA version: 18.0 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Intervention(s)

Product Name: Cebranopadol 200 µg film-coated tablet
Product Code: GRT6005
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cebranopadol
Current Sponsor code: GRT6005
Other descriptive name: CEBRANOPADOL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-

Product Name: Cebranopadol 400 µg film-coated tablet
Product Code: GRT6005
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cebranopadol
Current Sponsor code: GRT6005
Other descriptive name: CEBRANOPADOL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 400-

Product Name: Cebranopadol 600 µg film-coated tablet
Product Code: GRT6005
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cebranopadol
Current Sponsor code: GRT6005
Other descriptive name: CEBRANOPADOL
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

Main Objective: The primary objective of this trial is to describe the safety and tolerability of prolonged exposure to cebranopadol in subjects suffering from cancer related pain

Primary end point(s): The primary endpoint for this trial is the incidence of treatment emergent adverse events (TEAEs).

Timepoint(s) of evaluation of this end point: First intake of IMP up to the time of the last protocol scheduled contact

Secondary Objective: Not applicable

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Secondary safety endpoint: first intake of IMP up to the time of the last protocol scheduled contact. Secondary efficacy endpoint: last week during the Treatment Period and changes from baseline

Secondary end point(s): The secondary safety endpoint for this trial is the intensity of TEAEs. The secondary efficacy endpoint for this trial is the average pain intensity (11-point numerical rating scale [NRS]) in the last week during the Treatment Period and changes from baseline (Visit 1).

Secondary ID(s)

KF6005/09

2013-001877-26-SE

Source(s) of Monetary Support

Grünenthal GmbH