Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
NCT ID: NCT02522780
Last Updated: 2021-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2016-02-01
2018-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mesalamine
Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.
Mesalamine
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Placebo
Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Placebo
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Interventions
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Mesalamine
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Placebo
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Infectious disease (including human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\])
* Disease limited to proctitis \<15 cm
* Short bowel syndrome
* Prior colon resection surgery
* History of severe/fulminant UC
* Intolerant or allergic to aspirin or salicylate derivatives
* Use of rectal formulations (5-aminosalicylic acid \[5-ASA\], steroids) within ≤7 days
* Women who are pregnant or nursing
* History of known malignancy
* History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial
18 Years
75 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Preferred Research Partners
Little Rock, Arkansas, United States
United Research Institute
Murrieta, California, United States
Research Associates of South Florida, LLC
Miami, Florida, United States
IMIC
Palmetto Bay, Florida, United States
Medical Research Center of Florida
Pembroke Pines, Florida, United States
Lenus Research and Medical Group
Sweetwater, Florida, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Wilmington Gastroenterology Associates
Wilmington, North Carolina, United States
Associates in Gastroenterology, PLC
Hermitage, Tennessee, United States
Quality Medical Research, PLLC
Nashville, Tennessee, United States
BI Research Center
Houston, Texas, United States
Biopharma Informatic Inc.
Houston, Texas, United States
Digestive Health Center
Pasadena, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, United States
Multiprofile Hospital For Active Treatment Avis Medica
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment Kaspela
Plovdiv, , Bulgaria
Medical Center Excelsior OOD
Sevlievo, , Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, , Bulgaria
City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, , Bulgaria
Medical Center Asklepion - Humane Medicine Research EOOD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, , Bulgaria
Diagnostic Consultative Centre Mladost M OOD
Varna, , Bulgaria
Topstone Research Institute
Ottawa, Ontario, Canada
Toronto Digestive Disease Associates Inc
Toronto, Vaughan, Canada
Magyar Honvédség Egészségügyi Központ
Budapest, , Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, , Hungary
Semmelweis Egyetem Institute
Budapest, , Hungary
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
Debrecen, , Hungary
ENDOMEDIX Kft.
Miskolc, , Hungary
Karolina Korhaz Rendelointezet
Mosonmagyaróvár, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Polana-D, LTD
Daugavpils, , Latvia
Digestive Diseases Centre Gastro
Riga, , Latvia
Latvian Maritime Medicine Centre
Riga, , Latvia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
ICARO Investigaciones en Medicina, S.A de C.V
Chihuahua City, , Mexico
Maria Auxiliadora Hospital
Guadalajara, , Mexico
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
Zapopan, , Mexico
Osrodek Medycyny Rodzinnej Sp. z o.o.
Sobótka, Lower Silesian Voivodeship, Poland
Lexmedica
Wroclaw, Lower Silesian Voivodeship, Poland
Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.
Warsaw, Masovian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Intermed
Częstochowa, , Poland
Economicus - NZOZ ALL-MEDICUS
Katowice, , Poland
Investigational site
Ksawerów, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
Lodz, , Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, , Poland
Endoskopia Sp. z o.o.
Sopot, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Regional Clinical Hospital
Krasnoyarsk, , Russia
City Clinical Hospital # 51
Moscow, , Russia
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, , Russia
Novosibirsk State Medical University
Novosibirsk, , Russia
Research Institute of Physiology of Sibirian Branch the RAMS
Novosibirsk, , Russia
Omsk State Medical Academy
Omsk, , Russia
Rostov State Medical University
Rostov-on-Don, , Russia
Ryazan Regional Clinical Hospital
Ryazan, , Russia
State Budget Institution of Ryazan region" Regional Clinical Hospital"
Ryazan, , Russia
City Hospital #31
Saint Petersburg, , Russia
City Polyclinic #38
Saint Petersburg, , Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, , Russia
Medical Company "Hepatolog", LLC
Samara, , Russia
Stavropol State Medical Academy
Stavropol, , Russia
Clinical Hospital Centar Zvezdara
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Health Center Valjevo
Valjevo, , Serbia
Inselspital Bern
Bern, , Switzerland
Investigational site
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
Kyiv Municipal Clinical Hospital #18
Kyiv, Kyïv, Ukraine
Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv
Kyiv, Kyïv, Ukraine
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, , Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov
Dnipropetrovsk, , Ukraine
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
Kharkiv, , Ukraine
SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
Kharkiv, , Ukraine
Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"
Kherson, , Ukraine
Private Enterprise Private Manufactire Company "Acinus"
Kirovohrad, , Ukraine
Kremenchuk city Hospital # n.a O.T.Bohaievskyi
Kremenchuk, , Ukraine
Kyiv City Clinical Hospital #8
Kyiv, , Ukraine
Kyiv Municipal Clinical Hospital #18
Kyiv, , Ukraine
Medical Center Universal Clinic Oberih of LLC Kapytal
Kyiv, , Ukraine
Municipal City Clinical emergency Hospital
Lviv, , Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, , Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia, , Ukraine
Small Business Private Enterprise Medical Center "Pulse"
Vinnytsia, , Ukraine
Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov
Vinnytsia, , Ukraine
Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
Zaporizhzhia, , Ukraine
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, , Ukraine
Medical Centre of PE First Private Clinic
Zhytomyr, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002558-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000175
Identifier Type: -
Identifier Source: org_study_id