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Spots Global Cancer Trial Database for CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Director Clinical Trials

Affiliation: Grünenthal GmbH

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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