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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01939366

Public ClinicalTrials.gov record NCT01939366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01939366
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Tris Pharma, Inc.
Industry
Enrollment
699 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 27, 2013 (Actual)
Primary completion
Jan 2015 (Actual)
Completion
Jan 28, 2015 (Actual)
Last update posted
Jul 15, 2021

2013 – 2015

United States locations

U.S. sites
15
U.S. states
8
U.S. cities
14
Facility City State ZIP Site status
US002 Mesa Arizona 85215 —
US001 Garden Grove California 92843 —
US019 Laguna Hills California 92653 —
US014 National City California 91950 —
US007 Orange California 92868 —
US011 Hialeah Florida 33012 —
US012 Miami Florida 33135 —
US009 Orlando Florida 32806 —
US004 Blackfoot Idaho 83221 —
US006 Elgin Illinois 60123 —
US016 West Long Branch New Jersey 07764 —
US008 Brooklyn New York 11229 —
US005 Brooklyn New York 11235 —
US021 New York New York 10128 —
US003 West Jordan Utah 84088 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01939366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01939366 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →