Clinical trial NCT02522767: Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate 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: 228
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 is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 75 years
* Mild to moderate UC

Exclusion Criteria:

* Disease limited to proctitis \<15 cm
* Short bowel syndrome
* Prior colon resection surgery
* History of severe/fulminant UC
* Evidence of other forms of inflammatory bowel disease
* Infectious disease (including human immunodeficiency virus \[HIV\], hepatitis B virus \[HBV\], or hepatitis C virus \[HCV\])
* 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 or 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
timeFrame: At Week 8
Secondary outcomes:
measure: Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
timeFrame: At Week 8
measure: Time to Cessation of Rectal Bleeding
timeFrame: Up to Week 8
measure: The Proportion of Subjects With Endoscopic Improvement
timeFrame: At Week 8
measure: The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
timeFrame: At Week 2, 4, and 8
measure: Time to Normal Stool Pattern
timeFrame: Up to Week 8
measure: The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8
timeFrame: From baseline to Week 2, 4, and 8
measure: The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8
timeFrame: From baseline to Week 2, 4, and 8
measure: The Change From Baseline in Fecal Calprotectin Levels at Week 8
timeFrame: From baseline to Week 8
measure: The Change From Baseline in Health Related Quality of Life (QoL) Scores
timeFrame: From baseline to Week 2, 4, and 8
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to Week 16
measure: Severity of Adverse Events
timeFrame: Up to Week 16
measure: Proportion of Subject With Abnormal Laboratory Values (Hematology)
timeFrame: Up to Week 16
measure: Proportion of Subjects With Abnormal Laboratory Values (Coagulation)
timeFrame: Up to Week 16
measure: Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)
timeFrame: Up to Week 16
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: 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: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates
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: Investigational site
city: Warsaw
country: Poland
facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy
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: 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: Railway Clinical Hospital at Station Samara OAO Rzhd
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: 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: