Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
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
2 other identifiers
interventional
228
11 countries
93
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2015
Typical duration for phase_3
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2018
CompletedResults Posted
Study results publicly available
March 15, 2021
CompletedMarch 15, 2021
February 1, 2021
2.4 years
August 12, 2015
January 8, 2021
February 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With Remission
The proportion of subjects with remission was defined by the Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 with at least 1 point decrease from baseline for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0-9, higher scores indicating greater disease severity. This score had two components: Clinical Response which assessed subject's symptoms and ranged between 0-6, and Endoscopic Response which assessed objective evidence of inflammation and ranged between 0-3. Further, the Clinical Response component included two subscales: stool frequency and rectal bleeding (each ranged between 0-3 each) obtained from subjects' daily records. The Endoscopic Response component had one subscale: flexible sigmoidoscopy/colonoscopy (ranging between 0-3).
At Week 8
Secondary Outcomes (14)
Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
At Week 8
Time to Cessation of Rectal Bleeding
Up to Week 8
The Proportion of Subjects With Endoscopic Improvement
At Week 8
The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
At Week 2, 4, and 8
Time to Normal Stool Pattern
Up to Week 8
- +9 more secondary outcomes
Study Arms (2)
Mesalamine
EXPERIMENTAL4 g extended release granules (sachet)
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 18 to 75 years
- Mild to moderate UC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
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, 37076, 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
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
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
Investigational site
Sopot, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
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
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
Railway Clinical Hospital at Station Samara OAO Rzhd
Samara, Russia
Stavropol State Medical Academy
Stavropol, Russia
Clinical Hospital Centar Zvezdara
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2015
First Posted
August 13, 2015
Study Start
October 1, 2015
Primary Completion
February 6, 2018
Study Completion
April 3, 2018
Last Updated
March 15, 2021
Results First Posted
March 15, 2021
Record last verified: 2021-02