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

NCT01939366 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 699

Last updated 2021-07-15

Study results available
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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

Interventions

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.

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
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-27
Primary Completion
2015-01-31
Completion
2015-01-28
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01939366 on ClinicalTrials.gov