NCT02031432

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cebranopadol	Film-coated tablet; strengths: 200, 400, or 600 µg

Timeline

• Start date: 2013-12-18
• Primary completion: 2016-04-01
• Completion: 2016-05-03
• First posted: 2014-01-09
• Last updated: 2021-07-15
• Results posted: 2020-01-18

Locations

22 sites across 10 countries: Austria, Belgium, Bulgaria, Denmark, Germany, Hungary, Poland, Romania, Serbia, Slovakia