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CORAL – CEBRANOPADOL VERSUS MORPHINE PROLONGED-RELEASE IN PATIENTS WITH CHRONIC MODERATE TO SEVERE PAIN RELATED TO CANCER

EFFICACY, SAFETY, AND TOLERABILITY OF ORAL CEBRANOPADOL VERSUS MORPHINE SULFATE PR IN SUBJECTS WITH CHRONIC MODERATE TO SEVERE PAIN RELATED TO CANCER.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-041-13
Enrollment
53
Registered
2013-12-26
Start date
2013-12-02
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1. Cebranopadol treatment arm: - Pharmaceutical form: Cebranopadol film-coated tablets -Frequency: Once daily. - Dose: 200 &#956
g, 400 &#956
g, and 600 &#956
g. - Route administration: Oral - Duration: The minimum daily dose will be cebranopadol 200 &#956
g, the maximum daily dose will be cebranopadol 1000 &#956
g. Additionally, subjects will receive morphine PR-matching placebo capsules in the morning and in the evening. 2. Morphine PR treatment arm: - Pharmaceutical form: Over-encapsulated morphine s

Sponsors

GRUNENTHAL GmbH,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Subjects must have signed an informed consent orm (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. Complementary information is in protocol.

Exclusion criteria

Exclusion criteria: 1. Evidence of ongoing alcohol/drug abuse or history of alcohol/drug abuse within the last 2 years in the investigator’s judgment, based on patient history and physical examination. Complementary information is in protocol.

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Chile, Croatia, Denmark, France, Germany, Hungary, Mexico, Netherlands, Peru, Poland, Romania, Slovakia, Spain, Sweden, United Kindgdom, Yugoslavia

Contacts

Public ContactMaria del Rosario Torres

GRUNENTHAL PERUANA S.A.

Rosario.Torres@grunenthal.com5190600

Outcome results

None listed

Source: REPEC (via WHO ICTRP)