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

COMPLETED Phase 2

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

NCT01939366 · View on ClinicalTrials.gov ↗

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.

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

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 699 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tris Pharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01939366 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01939366?

This trial is sponsored by Tris Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial