drugset / Trial / NCT01939366

Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves

NCT01939366

Phase 2 Completed 699 enrolled Tris Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment. The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

Timeline

Start
2013-09-27
Primary completion
2015-01
Completion
2015-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Cebranopadol Small molecule 100 ug Oral
Subject Cebranopadol Small molecule 300 ug Oral
Subject Cebranopadol Small molecule 600 ug Oral
Comparator Pregabalin Small molecule 300 mg