Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01939366 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Chronic Pain and Diabetes Mellitus, sponsored by Tris Pharma.

Completed
Registry status
Phase 2
Development phase
699
Enrollment target
20
Study locations

NCT01939366 is a Phase 2 study of Chronic Pain and Diabetes Mellitus that has completed, run by Tris Pharma. The registered enrollment target is 699 participants, roughly in line with the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target. The trial reports 20 study locations across 9 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01939366, a Phase 2 study of Chronic Pain and Diabetes Mellitus, has completed, sponsored by Tris Pharma.

COMPLETED
Registry status
Phase 2
Development phase
699 participants
Enrollment target
20
Study locations

Study 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 Studied

Chronic Pain Diabetes Mellitus Diabetic Neuropathies

Interventions

  • DRUG Matching Placebo
  • DRUG Pregabalin
  • DRUG Cebranopadol 100 µg
  • DRUG Cebranopadol 300 µg
  • DRUG Cebranopadol 600 µg

Study Locations (20)

Other

  • AT007 - Graz
  • AT005 - Salzburg
  • AT004 - Senftenberg
  • AT002 - Vienna
  • AT003 - Vienna

California

  • US001 - Garden Grove
  • US019 - Laguna Hills
  • US014 - National City
  • US007 - Orange

Florida

  • US011 - Hialeah
  • US012 - Miami
  • US009 - Orlando

New York

  • US008 - Brooklyn
  • US005 - Brooklyn
  • US021 - New York

Arizona

  • US002 - Mesa

Idaho

  • US004 - Blackfoot

Illinois

  • US006 - Elgin

New Jersey

  • US016 - West Long Branch

Trial Details

FieldValue
Enrollment Target 699 participants
Start Date 2013-09-27
Est. Completion 2015-01-28
Phase Phase 2

Sponsor

Tris Pharma

14 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01939366

The ClinicalTrials.gov registry entry for NCT01939366 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 699 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target. The listed sponsor is Tris Pharma, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 5 interventions - of which Matching Placebo is the first listed.

NCT01939366 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01939366 about?

NCT01939366 is a clinical study titled "Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves". 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 ...

What is the current status of trial NCT01939366?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 699 participants. The study started on 2013-09-27. Estimated completion is 2015-01-28.

What conditions does trial NCT01939366 study?

This clinical trial studies the following conditions: Chronic Pain, Diabetes Mellitus, Diabetic Neuropathies.

What interventions are being tested in trial NCT01939366?

The interventions under investigation include: Matching Placebo (DRUG), Pregabalin (DRUG), Cebranopadol 100 µg (DRUG), Cebranopadol 300 µg (DRUG), Cebranopadol 600 µg (DRUG).

Who is sponsoring clinical trial NCT01939366?

This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01939366 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Chronic Pain

All registered trials for this condition

Diabetes Mellitus

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.