CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer

NCT01964378 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-07-15

Study results available
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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).

Conditions

Interventions

DRUG

Cebranopadol

Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening.

DRUG

Morphine Prolonged Release

Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning.

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Director Clinical Trials · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-29
Primary Completion
2015-10-16
Completion
2015-10-16

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Chile
  • Croatia
  • Denmark
  • Germany
  • Hungary
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964378 on ClinicalTrials.gov