Conditions: Chronic Pain Diabetic Neuropathies Diabetes Mellitus
Keywords: Painful Diabetic Peripheral Neuropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 699
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Cebranopadol 100 µg intervention 2: Cebranopadol 300 µg intervention 3: Cebranopadol 600 µg intervention 4: Pregabalin intervention 5: Matching Placebo
Intervention descriptions: intervention 1: Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day. intervention 2: 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. intervention 3: 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. intervention 4: Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks. intervention 5: Placebo will be matched to pregabalin and cebranopadol.

Protocol document: