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

July 13, 2021 updated by: Tris Pharma, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
699

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • AT007
      • Salzburg, Austria, 5020
        • AT005
      • Senftenberg, Austria, 3541
        • AT004
      • Vienna, Austria, 1090
        • AT001
      • Vienna, Austria, 1010
        • AT002
      • Vienna, Austria, 1060
        • AT003
      • Vienna, Austria, 1160
        • AT006
  • Denmark
      • Aalborg, Denmark, 9100
        • DK005
      • Aarhus, Denmark, 8000
        • DK003
      • Copenhagen, Denmark, 2000
        • DK002
      • Odense, Denmark, 5000
        • DK001
  • France
      • Corbeil Essonnes, France, 91100
        • FR008
      • Lille, France, 59037
        • FR001
      • Limoges cedex, France, 87042
        • FR007
      • Montauban cedex, France, 82013
        • FR005
      • Nantes, France, 44200
        • FR002
      • Orléans, France, 45000
        • FR004
      • Paris, France, 75004
        • FR006
  • Germany
      • Aschaffenburg, Germany, 63739
        • DE018
      • Bad Oeynhausen, Germany, 32545
        • DE003
      • Berlin, Germany, 10115
        • DE005
      • Berlin, Germany, 10117
        • DE023
      • Berlin, Germany, 10787
        • DE031
      • Berlin, Germany, 12627
        • DE004
      • Berlin, Germany, 13125
        • DE025
      • Bochum, Germany, 44787
        • DE013
      • Dresden, Germany, 01069
        • DE033
      • Düsseldorf, Germany, 40210
        • DE017
      • Düsseldorf, Germany, 40212
        • DE012
      • Essen, Germany, 45136
        • DE010
      • Essen, Germany, 45277
        • DE034
      • Essen, Germany, 45355
        • DE022
      • Frankfurt, Germany, 60596
        • DE006
      • Görlitz, Germany, 02826
        • DE007
      • Hamburg, Germany, 20253
        • DE021
      • Hannover, Germany, 30159
        • DE020
      • Karlsruhe, Germany, 76199
        • DE016
      • Kiel, Germany, 24119
        • DE002
      • Künzing, Germany, 94550
        • DE030
      • Leipzig, Germany, 04103
        • DE008
      • Leipzig, Germany, 04109
        • DE009
      • Magdeburg, Germany, 39104
        • DE015
      • Magdeburg, Germany, 39112
        • DE032
      • Mainz, Germany, 55116
        • DE001
      • Mayen, Germany, 56727
        • DE028
      • München, Germany, 81477
        • DE027
      • Münster, Germany, 48145
        • DE014
      • Neuss, Germany, 41460
        • DE011
      • Schwerin, Germany, 19055
        • DE024
  • Italy
      • Ancona, Italy, 60127
        • IT005
      • Milano, Italy, 20162
        • IT004
      • Rome, Italy, 00133
        • IT001
      • Turin, Italy, 10126
        • IT002
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • NL007
      • Apeldoorn, Netherlands, 7334 DZ
        • NL004
      • Beek, Netherlands, 6191 JW
        • NL005
      • Eindhoven, Netherlands, 5623 EJ
        • NL001
      • Rotterdam, Netherlands, 3039 BD
        • NL002
      • Venlo, Netherlands, 5912 BL
        • NL006
      • Zwijndrecht, Netherlands, 3331 LZ
        • NL008
      • Zwolle, Netherlands, 8025 AB
        • NL003
  • Spain
      • Cuenca, Spain, 16002
        • ES001
      • Madrid, Spain, 28041
        • ES009
      • Madrid, Spain, 28031
        • ES011
      • Madrid, Spain, 28040
        • ES010
      • Toledo, Spain, 45600
        • ES003
      • Valencia, Spain, 46010
        • ES006
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85215
        • US002
    • California
      • Garden Grove, California, United States, 92843
        • US001
      • Laguna Hills, California, United States, 92653
        • US019
      • National City, California, United States, 91950
        • US014
      • Orange, California, United States, 92868
        • US007
    • Florida
      • Hialeah, Florida, United States, 33012
        • US011
      • Miami, Florida, United States, 33135
        • US012
      • Orlando, Florida, United States, 32806
        • US009
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • US004
    • Illinois
      • Elgin, Illinois, United States, 60123
        • US006
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • US016
    • New York
      • Brooklyn, New York, United States, 11229
        • US008
      • Brooklyn, New York, United States, 11235
        • US005
      • New York, New York, United States, 10128
        • US021
    • Utah
      • West Jordan, Utah, United States, 84088
        • US003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written signed informed consent
  • type 1 or type 2 diabetes mellitus
  • clinical diagnosis of painful Diabetic Polyneuropathic Neuropathy (DPN) with symptoms and signs for at least 3 months
  • must require medication (e.g., non-opioids or opioids up to an equivalent dose of 160 mg oral morphine/day) for the treatment of pain due to DPN for at least 1 month prior to Visit 1 and must be dissatisfied with the current treatment (in terms of efficacy and/or tolerability). Medication for the treatment of pain due to DPN should be required on at least 4 of 7 consecutive days.
  • blood glucose to be controlled by a diet, oral anti-hyperglycemic medication, and/or insulin for at least 3 months prior. Glycosylated hemoglobin (HbA1C) should not be greater than 11%
  • baseline pain intensity score greater or equal to 5 on the 11-point Numerical Rating Scale (NRS) without intake of any analgesic at allocation. For each of the last 3 days prior to allocation of treatment, a 24 hour NRS score greater or equal to 4 is required
  • women of childbearing potential must have a negative urine pregnancy test at enrollment
  • using medically acceptable and highly effective methods of birth control (and willing to use them during the trial).

Exclusion Criteria:

  • presence of other pain that could confound the painful Diabetic Polyneuropathy (DPN) assessments, e.g. pain due to nerve entrapment (tarsal tunnel syndrome, osteoarthritis of the knee etc), peripheral vascular disease, radiculopathy, plantar fasciitis, tendonitis, mononeuritis multiplex, postherpetic neuralgia, complex regional pain syndrome, or fibromyalgia.
  • neuropathy due to etiologies other than diabetes, e.g. autoimmune disorders, inflammatory neuropathies (e.g. chronic inflammatory demyelinating polyneuropathy), thyroid disease or endocrine disorders (other than diabetes), heavy metal or toxic neuropathy, nutritional deficiency, metabolic disorders, vasculitis, infections, injury, or paraneoplastic syndromes.
  • severe or extensive diabetic ulcers or amputations due to diabetes
  • Charcot's joints due to diabetes.
  • any clinically significant disease or laboratory findings, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
  • inability to comply with the protocol and with the intake of trial medication that, in the investigator's opinion, might indicate that the participant is unsuitable for the trial.
  • conditions that require treatment with medication that is not allowed to be taken during the trial
  • previous or current alcohol or drug abuse or opioid dependency.
  • severe functional hepatic impairment corresponding to Child-Pugh classification C.
  • history of acute hepatitis
  • impaired renal function, a creatinine clearance less than 60 mL/min at the enrollment (Cockcroft-Gault calculated).
  • history of any major gastrointestinal procedures (e.g., gastric bypass) or gastrointestinal conditions (e.g. acute diarrhea, blind loop syndrome, gastric dumping syndrome, Whipple's disease) that might affect the absorption or metabolism of cebranopadol or pregabalin.
  • risk factors for or history of torsade de pointes and/or marked prolongation of the QT interval (e.g. heart failure, hypokalemia, or bradycardia).
  • history of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy at the discretion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Matching Placebo
Drug: Matching Placebo
Placebo will be matched to pregabalin and cebranopadol.
ACTIVE_COMPARATOR: Pregabalin
Drug: Pregabalin
Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
Other Names:
  • Lyrica®
EXPERIMENTAL: Cebranopadol 300 µg
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.
EXPERIMENTAL: Cebranopadol 600 µg
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.
EXPERIMENTAL: Cebranopadol 100 µg
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Average Pain Intensity.
Time Frame: Baseline; to End of Week 6 of the Maintenance Phase
Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at week 6 will be the average pain scores calculated from all pain scores measured during week 6.
Baseline; to End of Week 6 of the Maintenance Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tris Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KF6005/08
  • 2013-000473-68 (EUDRACT_NUMBER)
  • U1111-1151-4331 (OTHER: WHO UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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