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

NCT02031432 | Completed Phase 3 Results

• 3 other identifiers: KF6005/092013-001877-26U1111-1144-0778
• Study Type: interventional
• Target: 76
• Locations: 10 countries
• Sites: 22

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.

Conditions

Pain; Neoplasms; Chronic Pain

Keywords

cancer-related pain; cebranopadol

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Intensity of Treatment Emergent Adverse Events

  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

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

Other Outcomes (19)

• Outcome of Treatment Emergent Adverse Events (TEAE)

  Baseline (Day 2) to End of trial (i.e., up to Week 28)

• Time to Onset of Treatment Emergent Adverse Events (TEAEs)

  Baseline (Day 2) to End of trial (up to Week 28)

• Duration of Treatment Emergent Adverse Events (TEAEs)

  Baseline (Day 2) to End of trial (up to Week 28)

Study Arms (1)

Cebranopadol

EXPERIMENTAL

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.

Drug: Cebranopadol

Interventions

Cebranopadol DRUG

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

Also known as: GRT6005

Cebranopadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tris Pharma, Inc.: lead

Study Sites (22)

AT004

Vienna, 1090, Austria

Location

BE001

Sint-Niklaas, 9100, Belgium

Location

BG001

Shumen, 9700, Bulgaria

Location

BG008

Sofia, 1330, Bulgaria

Location

BG003

Sofia, 1407, Bulgaria

Location

BG004

Sofia, 1407, Bulgaria

Location

DK006

Aalborg, 9000, Denmark

Location

DK004

Herlev, 2730, Denmark

Location

DE008

Böhlen, 4564, Germany

Location

DE010

Munich, 81377, Germany

Location

HU011

Nyíregyháza, 4400, Hungary

Location

PL012

Będzin, 42-500, Poland

Location

PL014

Dąbrowa Górnicza, 41-300, Poland

Location

PL003

Gdansk, 80-208, Poland

Location

PL010

Gliwice, 44-100, Poland

Location

RO002

Cluj-Napoca, 400015, Romania

Location

RS003

Belgrade, 11000, Serbia

Location

RS002

Kamenitz, 21204, Serbia

Location

RS005

Zrenjanin, 23000, Serbia

Location

SK004

Bratislava, 851 07, Slovakia

Location

SK001

Prešov, 08001, Slovakia

Location

SK005

Pruské, 018 52, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 31152783 RESULT

MeSH Terms

Conditions

Pain; Neoplasms; Chronic Pain; Cancer Pain

Interventions

6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

A limitation is the open-label design of the study. An extrapolation to a population not suffering from cancer-related pain is limited due to the nature of the underlying disorder.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Grünenthal GmbH

Clinical-Trials@grunenthal.com

+49 241 569 3223

Study Officials

• Director Clinical Trials

  Grünenthal GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 9, 2014
• Study Start: December 18, 2013
• Primary Completion: April 1, 2016
• Study Completion: May 3, 2016
• Last Updated: July 15, 2021
• Results First Posted: January 18, 2020

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (1); BU (4); DK (2); PL (4); SE (3); DE (2); HU (1); RO (1); SL (3)