Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC
NCT ID: NCT02808390
Last Updated: 2018-11-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2016-11-28
2017-07-31
Brief Summary
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Detailed Description
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The study will consist of 3 phases:
* Screening Phase - up to 4 weeks
* Double-blind Placebo-controlled Phase - Weeks 0 to 8
* Follow-up Phase - Week 9
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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80 mg BID
GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 80 mg
GED-0507-34-Levo 80 mg BID for 8 Weeks
160 mg BID
GED-0507-34-Levo 160 mg BID for 8 Weeks
GED-0507-34-Levo 160 mg
GED-0507-34-Levo 160 mg BID for 8 Weeks
Placebo
Placebo BID for 8 Weeks
Placebo
Placebo BID for 8 Weeks
Interventions
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GED-0507-34-Levo 80 mg
GED-0507-34-Levo 80 mg BID for 8 Weeks
GED-0507-34-Levo 160 mg
GED-0507-34-Levo 160 mg BID for 8 Weeks
Placebo
Placebo BID for 8 Weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of UC with a duration of at least 3 months prior to the Screening Visit.
* MMS ≥ 4 to ≤ 8 (range: 0 - 9) prior to randomization in the study
* Subjects are required to have a colonoscopy if one has not been performed within 12 months prior to the Screening Visit.
* Subjects who have relapsed on maintenance therapy with doses of 5-ASA ≤ 2.4 g/day
Exclusion Criteria
* UC restricted to the distal 15 cm or less (eg, ulcerative proctitis).
* Subjects who have had surgery as a treatment for UC or who, in the opinion of the Investigator, are likely to require surgery for UC during the study.
* Clinical signs suggestive of fulminant colitis or toxic megacolon.
* Evidence of pathogenic enteric infection.
* History of colorectal cancer or colorectal dysplasia.
* Prior use of any TNF inhibitor (or any biologic agent).
* Prior use of mycophenolic acid, tacrolimus, sirolimus, cyclosporine, or thalidomide.
* Use of budesonide-MMx within the last 8 weeks.
* Use of oral and/or IV corticosteroids within 2 weeks of the Screening Visit.
* Use of immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\] or methotrexate \[MTX\]) within 8 weeks of the Screening Visit.
18 Years
ALL
No
Sponsors
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PPM Services S.A.
OTHER
Responsible Party
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Locations
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Clinical Applications Laboratories, Inc.
San Diego, California, United States
Center for Advanced Gastroenterology, PLLC
Maitland, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
IMIC, Inc
Palmetto Bay, Florida, United States
BRCR Medical Center, Inc
Pembroke Pines, Florida, United States
Mount Sinai
New York, New York, United States
Penn State University Milton S. Hershey Medical Center
State College, Pennsylvania, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Envision Clinical Research, LLC
Laredo, Texas, United States
Sagact, Pllc
San Antonio, Texas, United States
Medical Centre "Asklepii", OOD
Dupnitsa, , Bulgaria
MHAT - Pazardzhik AD
Pazardzhik, , Bulgaria
UMHAT "Sv. Georgi", EAD
Plovdiv, , Bulgaria
MHAT "Sv. Karidad", EAD
Plovdiv, , Bulgaria
MHAT - Silistra AD
Silistra, , Bulgaria
MHAT "Sv. Petka" - Vidin, AD
Vidin, , Bulgaria
Brandon Medical Arts Clinic
Brandon, Manitoba, Canada
Humber River Hospital
Toronto, Ontario, Canada
CHU Amiens - Hopital Sud, Service d'Hépato-Gastroentérologie
Amiens, , France
Cabinet Médical de Gastro-entérologie Dr.Lesage
Armentières, , France
Hôpital Claude Huriez - CHU Lille, Service des maladies de l'appareil digestif
Lille, , France
Cabinet Médical de Gastroentérologie Dr. Bismuth
Lille, , France
Cabinet Médical de Gastroentérologie Dr. Ben Ali
Roubaix, , France
Cabinet Médical de Gastro-entérologie Dr.Vernier Massouille
Tourcoing, , France
Principal SMO Kft.
Baja, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Endomedix Diagnosztikai Kozpont
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Bugat Pal Korhaz, Gasztroenterologia
Gyöngyös, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Gastroenterologiai Osztaly
Kaposvár, , Hungary
Mazso-Pharma Kutatasfejlesztesi Kft
Szeged, , Hungary
Fondazione IRCCS Ospedale Maggiore, Policlinico Mangiagalli e Regina Elena. Dipartimento di Medicina e Specialità Mediche
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Dipartimento di Medicina Interna
Roma, , Italy
Policlinico Universitario Agostino Gemelli, UOC Medicina Interna e gastroenterologia - CIC
Rome, , Italy
Polana D LLC
Daugavpils, , Latvia
J.Seleznovs Doctor Practice
Jelgava, , Latvia
Health Center 4, Affiliate Diagnostic Center
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Pauls Stradins Clinical University Hospital SLLC
Riga, , Latvia
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno, , Poland
Korczowski Bartosz, Gabinet Lekarski, Private Pediatric Office
Rzeszów, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej SONOMED
Szczecin, , Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, , Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, , Poland
Alian s.r.o.
Bardejov, , Slovakia
B+B MED, s.r.o., Gastroenterologicka ambulancia, MUDr. Brandeburova
Košice, , Slovakia
Gastromedic, s.r.o
Nové Zámky, , Slovakia
Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU
Kyiv, , Ukraine
CI of Kyiv RC Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU
Lviv, , Ukraine
Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
Lviv, , Ukraine
CI Odesa Regional Clinical Hospital, Center of Gastroenterology
Odesa, , Ukraine
CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI,Chair of Internal Medicine of PGE
Sumy, , Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, , Ukraine
Vinnytsya RCH for Patriotic War Invalides Therapeutic Dept # 1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, , Ukraine
CI City Clinical Hospital #6 Dept of Gastroenterology
Zaporizhzhia, , Ukraine
CI City Hospital #1, Dept of Surgery
Zaporizhzhia, , Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GED0507-UC-001
Identifier Type: -
Identifier Source: org_study_id
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