Propionyl-L-Carnitine in Ulcerative Colitis

Summary

The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).

Conditions

• Ulcerative Colitis

Interventions

DRUG

Propionyl-L-Carnitine

PLC colon release tablet 1 g/die for 4 weeks

DRUG

Propionyl-L-Carnitine

PLC colon release tablet 2 g/die for 4 weeks

DRUG

Placebo

Placebo PLC colon release tablet 2 g/die for 4 weeks

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.

  lead INDUSTRY

Principal Investigators

• Giovanni B. Gasbarrini, M.D. · Policlinico Universitario "A. Gemelli" - Rome - Italy

• Gabriele Bianchi Porro, M.D. · Ospedale "L. Sacco" - Milan - Italy

• Agesilao D'Arienzo, M.D. · A.O. Universitaria Federico II - Naples - Italy

• Daniela Valpiani, M.D. · P.O. Morgagni Pierantoni - Forlì - Italy

• Maurizio Koch, M.D. · Ospedale "S. Filippo Neri" - Rome - Italy

• Ewa Malecka-Panas, M.D. · Klinika Przewodu Pokarmowego Szpital Kliniczny Nr 1 - Lodz - Poland

• Leszek Paradowski, M.D. · Samodzielny Publiczny Szpital Kliniczny Nr 3 - Wroclaw - Poland

• Konrad Lesniakowski, M.D. · Wojewodzki Szpital - Wroclaw - Poland

• Limas Kupcinskas, M.D. · Kaunas Medical University Clinic - Kaunas - Lithuania

• Goda Denapiene, M.D. · Vilnius University Santariskiu Hospital - Vilnius - Lithuania

• Vladimir B. Grinevich, M.D. · State Institution "Regional Military Clinical Hospital N°422 named after Solovyov of Ministry of Defence of Russia - Saint Petersburg - Russia

• Elena Sishkova, M.D. · Federal State Healthcare Institution "Clinical Hospital N°122 named after L.G. Sokolov of Federal Medical and Biological Agency" - Saint Petersburg - Russia

• Konstantin P. Zhidkov, M.D. · St Petersburg State Healthcare Institution "Municipal Hospital N°26" - Saint Petersburg - Russia

• Igor G. Bakulin, M.D. · Federal State Institution "7th Central Military Clinical Aviation Hospital of Ministry of Defence of Russia" - Moscow - Russia

• Tatiana L. Mikhailova, M.D. · Federal State Institution "State Scientific Centre of Coloproctology of Rosmedtechnologij" - Moscow - Russia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2009-04-30

Completion

2009-12-31

Countries

• Italy
• Lithuania
• Poland
• Russia

Study Locations