Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 28, 2016

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
Ulcerative Colitis
Interventions
DRUG

GED-0507-34-Levo 80 mg

GED-0507-34-Levo 80 mg BID for 8 Weeks

DRUG

GED-0507-34-Levo 160 mg

GED-0507-34-Levo 160 mg BID for 8 Weeks

DRUG

Placebo

Placebo BID for 8 Weeks

Trial Locations (60)

1088

Semmelweis Egyetem, Budapest

1139

Endomedix Diagnosztikai Kozpont, Budapest

2600

"Medical Centre Asklepii, OOD", Dupnitsa

3200

Bugat Pal Korhaz, Gasztroenterologia, Gyöngyös

3700

"MHAT Sv. Petka - Vidin, AD", Vidin

4002

"UMHAT Sv. Georgi, EAD", Plovdiv

4004

"MHAT Sv. Karidad, EAD", Plovdiv

4400

MHAT - Pazardzhik AD, Pazardzhik

6500

Principal SMO Kft., Baja

6722

Mazso-Pharma Kutatasfejlesztesi Kft, Szeged

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly, Kaposvár

7500

MHAT - Silistra AD, Silistra

10029

Mount Sinai, New York

16803

Penn State University Milton S. Hershey Medical Center, State College

20122

Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche, Milan

21005

Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU, Vinnytsia

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

32751

Center for Advanced Gastroenterology, PLLC, Maitland

33028

BRCR Medical Center, Inc, Pembroke Pines

33157

IMIC, Inc, Palmetto Bay

34653

Advanced Research Institute, Inc., New Port Richey

40022

CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE, Sumy

59037

Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif, Lille

59100

Cabinet Médical de Gastroentérologie Dr. Ben Ali, Roubaix

59130

Cabinet Médical de Gastroentérologie Dr. Bismuth, Lille

59200

Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille, Tourcoing

59280

Cabinet Médical de Gastro-entérologie Dr.Lesage, Armentières

65025

CI Odesa Regional Clinical Hospital, Center of Gastroenterology, Odesa

69035

CI City Clinical Hospital #6 Dept of Gastroenterology, Zaporizhzhia

69104

CI City Hospital #1, Dept of Surgery, Zaporizhzhia

69600

CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhia

76012

Texas Clinical Research Institute, LLC, Arlington

76104

Cook Children's Medical Center, Fort Worth

78041

Envision Clinical Research, LLC, Laredo

78212

Sagact, Pllc, San Antonio

79010

Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU, Lviv

79013

Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU, Lviv

80054

CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie, Amiens

88018

A. Novak Transcarpathian Regional Clinical Hospital, Uzhhorod

92103

Clinical Applications Laboratories, Inc., San Diego

94002

Gastromedic, s.r.o, Nové Zámky

R7A 0N7

Brandon Medical Arts Clinic, Brandon

M3M0B2

Humber River Hospital, Toronto

H-4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

00133

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna, Roma

00168

Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC, Rome

LV-5417

Polana D LLC, Daugavpils

LV-3001

J.Seleznovs Doctor Practice, Jelgava

LV-1003

Health Center 4, Affiliate Diagnostic Center, Riga

LV-1038

Riga East Clinical University Hospital, Riga

LV1002

Pauls Stradins Clinical University Hospital SLLC, Riga

64-100

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS, Leszno

35-302

Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office, Rzeszów

71-685

Niepubliczny Zaklad Opieki Zdrowotnej SONOMED, Szczecin

00-632

Centrum Zdrowia Matki, Dziecka i Mlodziezy, Warsaw

53-333

Ars-Medica S.C Rybak Maria, Rybak Zbigniew, Wroclaw

08501

Alian s.r.o., Bardejov

04022

B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova, Košice

03110

Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU, Kyiv

04107

CI of Kyiv RC Kyiv Regional Clinical Hospital, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PPM Services S.A.

OTHER

NCT02808390 - Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC | Biotech Hunter | Biotech Hunter