Clinical trial NCT02522780: Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria:

* Evidence of other forms of inflammatory bowel disease
* 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

Primary outcomes:
measure: Proportion of Subjects With Remission at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Proportion of Subjects in Clinical Remission at Month 2, 4, and 6
timeFrame: Month 2, 4, and 6
measure: Time to Relapse
timeFrame: Time from randomization to the day of withdrawal due to escalation of therapy (up to 6 months)
measure: Proportion of Subjects With an Increase From Baseline in the Clinical and Endoscopic Response Score by 2 or More Points in at Least 1 Component or by 1 or More Points in at Least 2 Components at Month 6
timeFrame: Month 6
measure: Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6
timeFrame: Baseline, Month 2, 4, and 6
measure: Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6
timeFrame: Baseline, Month 2, 4, and 6
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6
timeFrame: Baseline, Month 2, 4, and 6
measure: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Month 6
measure: Severity of Adverse Events
timeFrame: Up to Month 6
measure: Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology
timeFrame: Baseline, Month 6
measure: Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation
timeFrame: Baseline, Month 6
measure: Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Murrieta
country: United States
facility: United Research Institute
state: California
city: Miami
country: United States
facility: Research Associates of South Florida, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC
state: Florida
city: Pembroke Pines
country: United States
facility: Medical Research Center of Florida
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research and Medical Group
state: Florida
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology Associates
state: North Carolina
city: Hermitage
country: United States
facility: Associates in Gastroenterology, PLC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research, PLLC
state: Tennessee
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Pasadena
country: United States
facility: Digestive Health Center
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Norfolk
country: United States
facility: Digestive & Liver Disease Specialists
state: Virginia
city: Pleven
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Avis Medica
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Kaspela
city: Sevlievo
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: City Clinic University Multiprofile Hospital for Active Treatment EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Asklepion - Humane Medicine Research EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre Mladost M OOD
city: Ottawa
country: Canada
facility: Topstone Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Digestive Disease Associates Inc
state: Vaughan
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Institute
city: Debrecen
country: Hungary
facility: Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
city: Miskolc
country: Hungary
facility: ENDOMEDIX Kft.
city: Mosonmagyarovar
country: Hungary
facility: Karolina Korhaz Rendelointezet
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Daugavpils
country: Latvia
facility: Polana-D, LTD
city: Riga
country: Latvia
facility: Digestive Diseases Centre Gastro
city: Riga
country: Latvia
facility: Latvian Maritime Medicine Centre
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Chihuahua
country: Mexico
facility: ICARO Investigaciones en Medicina, S.A de C.V
city: Guadalajara
country: Mexico
facility: Maria Auxiliadora Hospital
city: Zapopan
country: Mexico
facility: Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
city: Sobótka
country: Poland
facility: Osrodek Medycyny Rodzinnej Sp. z o.o.
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Lexmedica
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Czestochowa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Intermed
city: Katowice
country: Poland
facility: Economicus - NZOZ ALL-MEDICUS
city: Ksawerow
country: Poland
facility: Investigational site
city: Lodz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Warsaw
country: Poland
facility: Instytut Pomnik Centrum Zdrowia Dziecka
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 51
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Novosibirsk
country: Russian Federation
facility: Research Institute of Physiology of Sibirian Branch the RAMS
city: Omsk
country: Russian Federation
facility: Omsk State Medical Academy
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Ryazan
country: Russian Federation
facility: State Budget Institution of Ryazan region" Regional Clinical Hospital"
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #31
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Samara
country: Russian Federation
facility: Medical Company "Hepatolog", LLC
city: St. Petersburg
country: Russian Federation
facility: City Polyclinic #38
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Centar Zvezdara
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Valjevo
country: Serbia
facility: Health Center Valjevo
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Bern
country: Switzerland
facility: Investigational site
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18
state: Kyïv
city: Kyiv
country: Ukraine
facility: Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv
state: Kyïv
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov
city: Kharkiv
country: Ukraine
facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
city: Kharkiv
country: Ukraine
facility: SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
city: Kherson
country: Ukraine
facility: Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"
city: Kirovohrad
country: Ukraine
facility: Private Enterprise Private Manufactire Company "Acinus"
city: Kremenchuk
country: Ukraine
facility: Kremenchuk city Hospital # n.a O.T.Bohaievskyi
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #8
city: Kyiv
country: Ukraine
facility: Kyiv Municipal Clinical Hospital #18
city: Kyiv
country: Ukraine
facility: Medical Center Universal Clinic Oberih of LLC Kapytal
city: Lviv
country: Ukraine
facility: Municipal City Clinical emergency Hospital
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Medical Clinical Research Center of Medical Center LLC Health Clinic
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov
city: Vinnytsya
country: Ukraine
facility: Small Business Private Enterprise Medical Center "Pulse"
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
city: Zhytomyr
country: Ukraine
facility: Medical Centre of PE First Private Clinic
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: