Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
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
2 other identifiers
interventional
276
11 countries
96
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2016
Typical duration for phase_3
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2018
CompletedResults Posted
Study results publicly available
September 14, 2021
CompletedNovember 8, 2021
September 1, 2019
2.6 years
August 12, 2015
August 17, 2021
November 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With Remission at Month 6
The proportion of subjects with remission was defined by Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0 (normal) to 9 (severe disease), higher scores indicating greater disease severity. The score included clinical response component to assess subject's symptoms and endoscopic response component to assess objective evidence of inflammation. Clinical response component had two subscales: stool frequency ranging from 0 (normal number of stools) to 3 (\>=5 stools more than normal) and rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes). The Endoscopic response component had one subscale: flexible sigmoidoscopy/colonoscopy ranging from 0 (normal) to 3 (severe disease). Data is presented cumulative for all pathways.
Month 6
Secondary Outcomes (11)
Proportion of Subjects in Clinical Remission at Month 2, 4, and 6
Month 2, 4, and 6
Time to Relapse
Time from randomization to the day of withdrawal due to escalation of therapy (up to 6 months)
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
Month 6
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6
Baseline, Month 2, 4, and 6
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6
Baseline, Month 2, 4, and 6
- +6 more secondary outcomes
Study Arms (2)
Mesalamine
EXPERIMENTALMesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.
Placebo
PLACEBO COMPARATORPlacebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Interventions
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Eligibility Criteria
You may qualify if:
- Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
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
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
February 1, 2016
Primary Completion
September 19, 2018
Study Completion
September 19, 2018
Last Updated
November 8, 2021
Results First Posted
September 14, 2021
Record last verified: 2019-09