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Brief Title: CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer
Official Title: Efficacy, Safety, and Tolerability of Oral Cebranopadol Versus Morphine Sulfate PR in Subjects With Chronic Moderate to Severe Pain Related to Cancer.
Study ID: NCT01964378
Brief Summary: Pain is one of the most common symptoms associated with malignant tumor. The purpose of this trial is to determine whether cebranopadol is as effective in patients with cancer related pain as morphine sulfate prolonged release (PR).
Detailed Description: The trial comprises an enrollment period, a treatment period (titration and maintenance), and a follow-up period. Participants will receive either cebranopadol or morphine PR for 44 days. Initially participants will be titrated after 2 and then every 4 days to a morphine PR or cebranopadol dose that provides adequate analgesia and is tolerated. The titration period is planned to last 16 days. Thereafter the dose of morphine PR or cebranopadol is to be kept stable for a further 28 days, i.e. no dose adjustments will be allowed during the maintenance period. This 28 day period is the maintenance period. The follow-up period is planned for up to 18 days after the end of last pain medication treatment intake.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AT004, Vienna, , Austria
BE005, Brussels, , Belgium
BE002, Ottignies, , Belgium
BE001, Sint-Niklaas, , Belgium
BG001, Shumen, , Bulgaria
BG008, Sofia, , Bulgaria
BG003, Sofia, , Bulgaria
BG006, Sofia, , Bulgaria
BG007, Sofia, , Bulgaria
BG004, Varna, , Bulgaria
BG005, Vratsa, , Bulgaria
CL005, Temuco, , Chile
HR001, Zagreb, , Croatia
DK006, Aalborg, , Denmark
DK004, Herlev, , Denmark
DE008, Böhlen, , Germany
DE010, München, , Germany
HU004, Gyula, , Hungary
HU002, Miskolc, , Hungary
HU011, Nyiregyhaza, , Hungary
PL008, Bydgoszcz, , Poland
PL012, Będzin, , Poland
PL013, Chorzów, , Poland
PL014, Dąbrowa Górnicza, , Poland
PL003, Gdansk, , Poland
PL010, Gliwice, , Poland
PL015, Warszawa, , Poland
PL002, Wloclawek, , Poland
RO001, Brasov, , Romania
RO002, Cluj-Napoca, , Romania
RO009, Constanta, , Romania
RO011, Craiova, , Romania
RS001, Belgrade, , Serbia
RS003, Belgrade, , Serbia
RS002, Sremska Kamenica, , Serbia
RS005, Zrenjanin, , Serbia
SK007, Bratislava, , Slovakia
SK004, Bratislava, , Slovakia
SK001, Prešov, , Slovakia
SK005, Pruské, , Slovakia
ES012, Barcelona, , Spain
UK004, Leeds, , United Kingdom
Name: Director Clinical Trials
Affiliation: Grünenthal GmbH
Role: STUDY_DIRECTOR