CORAL XT – Open-label extension trial of the CORAL trial
Research type
Research Study
Full 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.
IRAS ID
135581
Contact name
Sam Ahmedzai
Contact email
Sponsor organisation
Grünenthal GmbH
Eudract number
2013-001877-26
ISRCTN Number
N/A
Research summary
Moderate to severe pain in cancer patients is usually treated with drugs like morphine, which are known as opioid analgesics. A new strong analgesic drug (cebranopadol) has been developed and is now being tested in clinical trials.
The main aim of the CORAL extension trial is to find out how well cebranopadol is tolerated, and to find out what side effects may occur when the drug is taken every day over a longer period of time. In addition, information will be collected on how cebranopadol affects pain and well-being.
It is expected that about 220 patients (world-wide), aged 18 years or older and with moderate to severe chronic pain due to cancer, will take part in this trial. All patients will previously have undertaken the CORAL trial, which looks at how cebranopadol compares with morphine as a treatment for this type of pain.
The trial for each patient will take up to 28 weeks. The patient will come to the trial centre a total of 11 times during the trial; patients will also be contacted 4 times by telephone between trial centre visits.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0309
Date of REC Opinion
3 Dec 2013
REC opinion
Further Information Favourable Opinion