Trazodone in Painful Diabetic Neuropathy

Status Completed

Clinical Trial Summary

The aim of the study is to collect preliminary information on the effect of low doses of trazodone on pain intensity in patients with painful diabetic neuropathy and to evaluate the neuropathic pain symptoms, anxiety, sleep, quality of life, safety and tolerability.

Clinical Trial Description

This is a randomized, double-blind, placebo controlled, double-dummy, dose finding, parallel group, multicentre, international, prospective, pilot study.

The present study is planned to assess the efficacy and the safety of an 8-week treatment period with low doses of trazodone (30 mg daily or 60 mg total daily, respectively) administered to patients affected by painful diabetic neuropathy.

Gabapentin will be administered together with the investigational drug in open label conditions in order to assure an effective pharmacological treatment to all patients. A slow titration of gabapentin will be applied in this trial in order to control possible side effects when co-administered with trazodone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03202979
Study type	Interventional
Source	Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact
Status	Completed
Phase	Phase 2
Start date	May 16, 2017
Completion date	August 9, 2018

View Details

See also
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