Trazodone in Painful Diabetic Neuropathy

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

May 16, 2017

Primary Completion Date

August 9, 2018

Study Completion Date

August 9, 2018

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."

Trial Locations (20)

1027

Budai Irgalmasrendi Korhaz Belgyógyászati Centrum, Budapest

1083

Semmelweis Egyetem AOK I. sz. Belgyogyaszati Klinika, Budapest

3300

Markhot Ferenc Oktatokorhaz es Rendelointezet Diabetesz Gondozo, Eger

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz I. sz. Belgyogyaszati Osztaly, Gyula

6000

Bacs-Kiskun Megyei Korhaz II. sz. Belgyogyaszati Osztaly, Kecskemét

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Sz. Belgyogyaszati Klinika, Szeged

565 01

NEUROHK s.r.o., Choceň

412 01

Litnea s.r.o. Neurologicka ambulance, Litoměřice

570 01

Neurosanatio s.r.o., Litomyšl

710 00

MP-neuro s.r.o. Poliklinika Modry pavilon, Ostrava

532 03

Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice Neurologická klinika, Pardubice

149 00

Diabetologicka ambulance Milan Kvapil s.r.o., Prague

516 01

Vestra Clinics s.r.o., Rychnov Nad Knežnou

40-282

Silmedic Sp. z o.o., Katowice

40-648

Pro Familia Altera Sp. z o.o., Katowice

20-064

NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin

96-500

RCMed Oddział Sochaczew, Sochaczew

87-100

"Jeka Sławomir Niepubliczny Zakład Opieki Zdrowotnej Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna", Torun

00-465

NBR Polska Tomasz Klodawski, Warsaw

00-660

Medycyna Kliniczna, Warsaw

Sponsors
All Listed Sponsors
collaborator

Chiltern International Inc.

INDUSTRY

lead

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY