Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

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

A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

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

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Site 4502
  • Germany
      • Aschaffenburg, Germany, 63739
        • Site 4112
      • Bad Oeynhausen, Germany, 32545
        • Site 4109
      • Berlin, Germany, 10117
        • Site 4101
      • Berlin, Germany, 13125
        • Site 4110
      • Dresden, Germany, 01307
        • Site 4111
      • Hamburg, Germany, 20253
        • Site 4107
      • Hamburg, Germany, 22587
        • Site 4117
      • Hannover, Germany, 30159
        • Site 4108
      • Hannover, Germany, 30167
        • Site 4104
      • Heidelberg, Germany, 69120
        • Site 4115
      • Kiel, Germany, 24119
        • Site 4106
      • Lübeck, Germany, 23562
        • Site 4102
      • Mainz, Germany, 55116
        • Site 4103
      • Münster, Germany, 48145
        • Site 4105
      • Schwerin, Germany, 19055
        • Site 4113
      • Wangen, Germany, 88239
        • Site 4116
  • Romania
      • Bucuresti, Romania, 010496
        • Site 4405
      • Bucuresti, Romania, 011025
        • Site 4402
      • Sibiu, Romania, 550166
        • Site 4407
      • Timisoara, Romania, 300594
        • Site 4406
      • Târgu-Mureş, Romania, 540139
        • Site 4401

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:

  • Men and women, 18 to 75 years old.
  • Type 1 or type 2 diabetes.
  • Painful DPN symptoms and signs for at least 3 months.
  • Blood glucose controlled with medication.
  • Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
  • Prior analgesic medication.
  • Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.

Exclusion Criteria:

  • Impaired liver, cardiac or renal function.
  • Breastfeeding and pregnancy.
  • History of substance abuse, alcohol or medication.
  • Chronic gastrointestinal disease.
  • History of seizures and or epilepsy.
  • History or presence of malignancy.
  • Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
  • Allergies to opioids, acetaminophen or excipients of the medications.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 25 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day
Drug: GRT6005
25µg/day once daily
Drug: GRT6005
75 µg/day once daily
Drug: GRT6005
200 µg/day once daily
Active Comparator: 75 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day
Drug: GRT6005
25µg/day once daily
Drug: GRT6005
75 µg/day once daily
Drug: GRT6005
200 µg/day once daily
Active Comparator: 200 µg GRT6005
Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
Drug: GRT6005
25µg/day once daily
Drug: GRT6005
75 µg/day once daily
Drug: GRT6005
200 µg/day once daily
Placebo Comparator: Matching Placebo
Participants allocated to this treatment arm will receive a dose of matched placebo once a day.
Drug: Matching Placebo
Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean daily pain intensity score
Time Frame: Baseline to Week 4

Participants will be selected based on their medical history and clinical examination.

Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Response measured in percentage change of pain intensity from baseline
Time Frame: End of 4 Weeks
End of 4 Weeks
Changes in Quantitative Sensory Testing from baseline
Time Frame: Baseline, week 1 and week 4
Baseline, week 1 and week 4
Neuropathic Pain Scale, changes from baseline
Time Frame: End of 4 weeks
End of 4 weeks
Short Form of the Brief Pain Inventory, changes from baseline
Time Frame: End of 4 weeks
End of 4 weeks
Leeds Sleep Evaluation Questionnaire
Time Frame: End of treatment
End of treatment
Quality of Life Index -Short-Form-12®, from baseline
Time Frame: End of treatment
End of treatment
Patient's Global Impression of Change
Time Frame: End of treatment
End of treatment
Quality of Life EuroQoL-5 Dimension score, change from baseline
Time Frame: End of 4 weeks
End of 4 weeks
Rescue medication use
Time Frame: End of 4 weeks
End of 4 weeks
Clinical Opioid Withdrawal Scale
Time Frame: End of 4 weeks
End of 4 weeks
Plasma concentration
Time Frame: End of 4 weeks
End of 4 weeks

Collaborators and Investigators

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

Sponsor

Tris Pharma, Inc.

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Thomas Forst, Prof. Dr., ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany

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

May 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

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

  • 430409
  • 2010-022557-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Pain

Clinical Trials on GRT6005

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe