NCT01939366

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

Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 699 (actual)
• Sponsor: Tris Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain
• Diabetic Neuropathies
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Cebranopadol 100 µg	Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
DRUG	Cebranopadol 300 µg	Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
DRUG	Cebranopadol 600 µg	Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
DRUG	Pregabalin	Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
DRUG	Matching Placebo	Placebo will be matched to pregabalin and cebranopadol.

Timeline

• Start date: 2013-09-27
• Primary completion: 2015-01-01
• Completion: 2015-01-28
• First posted: 2013-09-11
• Last updated: 2021-07-15
• Results posted: 2019-12-26

Locations

82 sites across 8 countries: United States, Austria, Denmark, France, Germany, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study