Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

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

A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy

The purpose of this trial is to determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • 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

  • Germany
      • Bad Oeynhausen, Germany
        • Investigator 3
      • Mainz, Germany
        • Investigator 1
      • Münster, Germany
        • Investigator 2
  • United Kingdom
      • Manchester, United Kingdom
        • Investigator 4

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with pain at least NRS >4 due to painful diabetic polyneuropaty.

Exclusion Criteria:

  • Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients.
  • non Caucasian or Hispanic.
  • Concomitant painful disease.
  • Life-long history of seizure disorder or epilepsy.
  • Subjects with clinical relevant cardiac and vascular diseases.
  • Subjects with impaired renal function
  • Subjects with impaired hepatic function
  • Female subjects who are pregnant or breastfeeding.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Dose 1, 40 µg
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: B
Dose 2, 120 µg
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: C
Dose 3
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: D
Dose 4
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: E
Dose 5
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: F
Dose 6
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Experimental: G
Dose 7
Drug: GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
Active Comparator: H
Morphin
Drug: MS Continus®
60 mg, capsule, once daily
Placebo Comparator: I
Placebo
Drug: Placebo
liquid formulation and capsule, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average daily pain intensity
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values
Time Frame: 5 days
5 days

Collaborators and Investigators

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

Sponsor

Tris Pharma, Inc.

Investigators

  • Principal Investigator: Thomas Forst, Prof. Dr. med, IKFE, Parcusstr. 8, 55116 Mainz

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

April 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 449723

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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