Patients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed.

Hypoxia

Inflammation

Chronic Obstructive Pulmonary Disease

duodenal biopsy during gastroduodenal endoscopy

Grenoble University Hospital

Effects of Hypoxia and Inflammation on Citrulline Synthesis by Ornithine Transcarbamylase in Human Enterocytes

OCT activity in duodenal biopsy specimens will be measured at the end of the incubation period and compared between the 4 different groups (standard/inflammatory/hypoxic:inflammatory+hypoxic conditions)

University Hospital, Grenoble

AGIR à Dom

Modified release tablets containing 500 mg of propionyl-L-carnitine

Modified release tablets containing inert substances

Ulcerative Colitis

500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks

Propionyl-L-Carnitine

500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks

Placebo

Landeskrankenhaus-Universitätskliniken Innsbruck - Klinische Abteilung für Gastroenterologie und Hepatologie

Krankenhaus der Barmherzigen Brüder - Abteilung für Innere Medizin

Ordinationszentrum Döbling

Allgemeines Krankenhaus Wien - Universitätsklinik Klinik für Innere Medizin III

Centre Hospitalier Intercommunal Créteil 40 avenue de Verdun

Centre Hospitalier Universitaire Hôpital Nord - Service D'Hépato-Gastro-Entérologie

Centre Hospitalier Universitaire Hotel Dieu Service d'hépato-gastroentérologie

Hôpital de I´Archet 2 Service d'Hépato-Gastroentérologie et de Nutrition Clinicque, Pôle Digestif

Hôpital Nord - Dept. of Gastroenterology

Hôpital Robert Debré Service et Consultation d'Hépato-Gastro-Entérologie

Hopital Nord - CHU de Saint-Etienne Service de Gastro-Entérologie

Hôpital Rangueil Service de gastro-enterologie

Hôpital Brabois Service de gastro-enterologie

Charité Universitätsmedizin Berlin Universitätsklinik Charité, Campus Mitte Medizinische Poliklinik

Saint Josef Hospital Ruhr Universitaet Bochum Gudrunstraße 56

Klinikum Braunschweig

Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I

Universtätsklinikum Schleswig-Holstein Gastroenterologie

Universitätsklinikum Magdeburg A.ö.R. Klinik für Gastroenterologie, Hepatologie und Infektiologie

Universitätsmedizin Mannheim II. Medizinische Klinik

Praxis Prof. Dr. med. Herbert Kellner

Universitätklinikum Münster Medizinische Klinik und Poliklinik für Innere Medizin

Gastroenterologische Fachpraxis am Germania Campus

Elbe Klinikum Stade Innere Medizin, Abteilung Gastroenterology

Fovárosi Önkormányzat Péterfy Sándor Utcai Kórház

Semmelweis Egyetem 1st Internal Dept.

Pannónia Magánorvosi Centrum Kft.

Semmelweis Egyetem II. sz. Belgyógyászati Klinika

Békés Megyei Képviselotestület Pándy Kálmán Kórháza Semmelweis ulica 1

Kaposi Mór Megyei Oktató Kórhaz Belgyógyászati Osztály

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház II. sz. Belgyógyászati Osztály

Karolina Kórház Rendelointézet Belgyógyászat- Gasztroenterológiai Osztály

Clinfan Kft. SMO

CRU Hungary Kft.

Daugavpils Central Regional Hospital

Paula Stradina Clinical University Hospital Gastroenterology Centre

Latvian Maritime Medicine Centre

Digestive Disease Center GASTRO

Lietuvos sveikatos mokslu universiteto ligonine VšI Kauno klinikos Gastroenterologijos skyrius

Klaipedos jurininku ligonine Diagnostikos skyrius

VšI Mykolo Marcinkeviciaus ligonines

Vilniaus universiteto ligonine Santariškiu klinikos Hepatologijos, gastroenterologijos ir dietologijos centras

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Oddzial Gastroenterologii Ogólnej i Onkologicznej

Wojewódzki Szpital Specjalistyczny w Olsztynie Oddzial Gastroenterologii

Endoskopia Sp. z o.o.

Nzoz Vivamed

Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Klinika Gastroenterologii i Hepatologii

Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego we Wroclawiu Oddzial Gastroenterologii

LexMedica

ARS MEDICA s.c., Rybak Maria, Rybak Zbigniew

Fundación Hospital de Alcorcón Servicio de Gastroenterología

Centro Medico Teknon Servicio de Aparato Disgestivo

Hospital Universitario Virgen de la Arrixaca Servicio de Digestivo

Hospital Universitario La Princesa Unidad de Hepatología, Servicio de Gastroenterologia

Hospital Universitario La Paz Servico de Gastroenterologia

Corporació Sanitaria Parc Taulí Servicio de Digestivo

Hospital Universitario Marques de Valdecilla Servicio de Digestivo

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

Remission will be defined according with the overall modified Mayo score (Disease Activity Index). A score ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1 will be considered necessary to classify the patient in remission state.

Evaluation will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).

Evaluations will be performed by means of Disease Activity Index (DAI) sub-score (from 0 to 3).

Evaluated as an improvement of the histological index of at least 1 point

A validated specific questionnaire, the SIBDQ by McMaster university will be administered to evaluate changes in patients' quality of life

Haemoglobin, Haematocrit, RBC, WBC and differential count.

Standard intervals (PR, RR, QRS, QT) will be collected plus all rhythm abnormalities

Standard evaluation including renal and liver function, electrolytes and blood glucose

sigma-tau i.f.r. S.p.A.

PRA Health Sciences

Modified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

Tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.

Imelda Ziekenhuis

Universitaire Ziekenhuis Gasthuisberg

Universitair Ziekenhuis Gent

H. Hartziekenhuis Roeselare-Menen vzw

Derma Plus s.r.o.

Hepato-Gastroenterology HK s.r.o.

Fakultní nemocnice Olomouc

G.E.P. Clinic s.r.o.

MONSE s.r.o

Fakultní Thomayerova nemocnice s poliklinikou

Fakultní Nemocnice v Motole

Nemocnice Tábor, a.s.

Orlickoústecká Nemocnice a.s

Soroka University Medical Center

Shaare Zedek Medical Center

Hadassah Medical Organization, Ein Kerem

Meir Medical Center

Rabin Medical Center

Kaplan Medical Center

Tel Aviv Souraski Medical Center

Assaf Harofeh Medical Centre

Ospedale "G.B.Morgagni - L. Pierantoni"

Istituto Clinico Humanitas

Ospedale Luigi Sacco - Az. Osp. Dept. of Gastroenterology

Policlinico Universitario Federico II

IRCSS Policlinico San Matteo

Azienda Ospedaliera S. Camillo Forlanini, Roma

Policlinico Universitario Agostino Gemelli

Onze Lieve Vrouwe Gasthuis

Leids Universitair Medisch Centrum

UMC Utrecht

CMI de Gastroenterologie Dobru Daniela

Neomed Research

Centrul Medical Sana

Endocenter Medicina Integrativa SRL

Gastromedica SRL

Spitalul Clinic Judetean De Urgenta Sibiu

Policlinic Algomed SRL

State Scientific Centre of Coloproctology

State Educational Institution of Higher Professional Education Novosibirsk State Medical University

State Research Institute of Physiology of Siberian Branch of Russian Academy of Medical Sciences

GOU VPO Rostov State Medical University

Saint Petersburg GUZ City Policlinic 38

Regional Military Clinical Hospital ¿ 442 named after Z.P. Solovyov of Ministry of Defence of Russia

Saint-Petersburg State Institution of Health Protection City Hospital # 26

Krestovsky Medical Institute

Saratov City Hospital #2

Saint-Petersburg Medical Academy

State Educational Institution of Higher Professional Education "Stavropol State Medical Academy"

Clinical Hospital #2

NovaMed spol. s.r.o.

UNB Nemocnica Staré Mesto

ABAWI spol.s.r.o.

Lama Medical Care s.r.o., Gastroentero-hepatologicke centrum Thalion

Neštátna Gastroenterologická Ambulancia

KM Management sro

Gastro I.s.r.o.

GEA s.r.o Gastroenterologicka ambulancia

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

glutamine

hypoxia

glutamine/hypoxia

Effects of Hypoxia and Inflammation on Citrulline Synthesis by Ornithine Transcarbamylase in Human Enterocytes

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

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