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

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).

Timeline

Start

2013-10-29

Primary completion

2015-10-16

Completion

2015-10-16

Outcome

Met primary endpoint

Stopped (Enrollment): “low accrual made the study no longer feasible/decision not related to safety and efficacy”

registry analysis (non-inferiority test); Cebranopadol vs Morphine Prolonged Release; p < 0.0001; point-estimate -7.48 (95% CI -12.05 to -2.918); MMRM NCT01964378 ↗

registry analysis (non-inferiority test); Cebranopadol vs Morphine Prolonged Release; p < 0.0001; point-estimate -4.67 (95% CI -9.245 to -0.099); MMRM NCT01964378 ↗

paper For the primary endpoint, noninferiority of cebranopadol with and superiority over morphine PR were demonstrated PMID 30365202 ↗

Publications

• Results Eerdekens MH, Kapanadze S, Koch ED, Kralidis G, Volkers G, Ahmedzai SH, Meissner W. Cancer-related chronic pain: Investigation of the novel analgesic drug candidate cebranopadol in a randomized, double-blind, noninferiority trial. Eur J Pain. 2019 Mar;23(3):577-588. doi: 10.1002/ejp.1331. Epub 2019 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cebranopadol	Small molecule	200 ug	Oral
Subject	Cebranopadol	Small molecule	400 ug	Oral
Subject	Cebranopadol	Small molecule	600 ug	Oral
Subject	Cebranopadol	Small molecule	1000 ug	Oral
Comparator	Morphine Prolonged Release	Unknown	15 mg	Oral
Comparator	Morphine Prolonged Release	Unknown	30 mg	Oral
Comparator	Morphine Prolonged Release	Unknown	45 mg	Oral
Comparator	Morphine Prolonged Release	Unknown	150 mg	Oral

Indications