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Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

NCT01347671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2021-07-15

No results posted yet for this study

Summary

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

Conditions

  • Pain
  • Diabetic Neuropathies

Interventions

DRUG

GRT6005

25µg/day once daily

DRUG

GRT6005

75 µg/day once daily

DRUG

GRT6005

200 µg/day once daily

DRUG

Matching Placebo

Once daily

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Bulgaria
  • Germany
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01347671 on ClinicalTrials.gov