MedTrace Logo

Efficacy Study With 500 mg QD of TRO19622 vs Placebo in Patients With Painful Peripheral Diabetic Neuropathy

NCT00496457 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2016-11-22

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of TRO19622 administered PO daily for 6 weeks compared to placebo administered PO daily in patients with painful peripheral diabetic neuropathy.

Conditions

  • Diabetic Neuropathy

Interventions

DRUG

Experimental

Capsules of TRO19622 (125 mg)- Once a day before noon meal during 6 weeks

DRUG

Placebo comparator

4 Capsules of PBO per day before noon meal

Sponsors & Collaborators

Principal Investigators

  • Jean-Louis Abitbol, MD · Trophos, Parc Scientifique de Luminy - Case 931, Luminy Biotech Enterprises, 13288 Marseille Cedex9 - France

  • Dan Ziegler, MD · German Diabetes Center, German Diabetes Clinic, Leibniz Institute at the Heinrich-Heine University, Auf ´m Hennekamp 65, 40225 Dusseldorf, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Croatia
  • Germany
  • Latvia
  • Poland
  • Serbia

Study Locations

More Related Trials

Entities

Companies

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 NCT00496457 on ClinicalTrials.gov