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Trazodone in Painful Diabetic Neuropathy

NCT03202979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-09-28

No results posted yet for this study

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.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Trazodone 20 mg

Oral administration of trazodone 20 mg (corresponding to 10 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 60 mg. After the 8-week treatment period, patients will receive trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution) three times a day for 1-week tapering period in double blind conditions.

DRUG

Trazodone 10 mg

Oral administration of trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 30 mg. In order to maintain the study double-blind conditions,patients randomized in this group will be co-administered with placebo oral solution (5 drops). After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.

DRUG

Placebo

Oral administration of placebo oral solution (10 drops) three times a day, for 8-week treatment. After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions.

Sponsors & Collaborators

  • Chiltern International Inc.

    collaborator INDUSTRY

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

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
2017-05-16
Primary Completion
2018-08-09
Completion
2018-08-09

Countries

  • Czechia
  • Hungary
  • Poland

Study Locations

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Entities

Drugs

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 NCT03202979 on ClinicalTrials.gov