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Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mesalamine
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Preferred Research Partners
  • United Research Institute
  • Research Associates of South Florida, LLC
  • IMIC
  • Medical Research Center of Florida
  • Lenus Research and Medical Group
  • Clinical Trials of SWLA, LLC
  • Cumberland Research Associates, LLC
  • Wilmington Gastroenterology Associates
  • Associates in Gastroenterology, PLC
  • Quality Medical Research, PLLC
  • BI Research Center
  • Biopharma Informatic Inc.
  • Digestive Health Center
  • DM Clinical Research
  • Advanced Research Institute
  • New River Valley Research Institute
  • Digestive & Liver Disease Specialists
  • Multiprofile Hospital For Active Treatment Avis Medica
  • University Multiprofile Hospital for Active Treatment Kaspela
  • Medical Center Excelsior OOD
  • Medical Center-1-Sevlievo EOOD
  • City Clinic University Multiprofile Hospital for Active Treatment EOOD
  • Medical Center Asklepion - Humane Medicine Research EOOD
  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
  • Diagnostic Consultative Centre Mladost M OOD
  • Topstone Research Institute
  • Toronto Digestive Disease Associates Inc
  • Magyar Honvédség Egészségügyi Központ
  • Pannónia Magánorvosi Centrum Kft
  • Semmelweis Egyetem Institute
  • Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
  • ENDOMEDIX Kft.
  • Karolina Korhaz Rendelointezet
  • Clinfan Kft.
  • Polana-D, LTD
  • Digestive Diseases Centre Gastro
  • Latvian Maritime Medicine Centre
  • Pauls Stradins Clinical University Hospital
  • Riga East Clinical University Hospital
  • ICARO Investigaciones en Medicina, S.A de C.V
  • Maria Auxiliadora Hospital
  • Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
  • Osrodek Medycyny Rodzinnej Sp. z o.o.
  • Lexmedica
  • Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Centrum Badan Klinicznych PI-House sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej Intermed
  • Economicus - NZOZ ALL-MEDICUS
  • Investigational site
  • Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
  • Endoskopia Sp. z o.o.
  • Instytut Pomnik Centrum Zdrowia Dziecka
  • Regional Clinical Hospital
  • City Clinical Hospital # 51
  • Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
  • Novosibirsk State Medical University
  • Research Institute of Physiology of Sibirian Branch the RAMS
  • Omsk State Medical Academy
  • Rostov State Medical University
  • Ryazan Regional Clinical Hospital
  • State Budget Institution of Ryazan region" Regional Clinical Hospital"
  • City Hospital #31
  • Russian Medical Military Academy n.a. S.M. Kirov
  • Medical Company "Hepatolog", LLC
  • City Polyclinic #38
  • Stavropol State Medical Academy
  • Clinical Hospital Centar Zvezdara
  • Clinical Hospital Center Bezanijska Kosa
  • Health Center Valjevo
  • Inselspital Bern
  • Investigational site
  • Universitätsspital Zürich
  • Kyiv Municipal Clinical Hospital #18
  • Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv
  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
  • Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov
  • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
  • SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
  • Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"
  • Private Enterprise Private Manufactire Company "Acinus"
  • Kremenchuk city Hospital # n.a O.T.Bohaievskyi
  • Kyiv City Clinical Hospital #8
  • Kyiv Municipal Clinical Hospital #18
  • Medical Center Universal Clinic Oberih of LLC Kapytal
  • Municipal City Clinical emergency Hospital
  • Municipal Institution Odesa Regional Clinical Hospital
  • Medical Clinical Research Center of Medical Center LLC Health Clinic
  • Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov
  • Small Business Private Enterprise Medical Center "Pulse"
  • Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • Medical Centre of PE First Private Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesalamine

Placebo

Arm Description

Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.

Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of Subjects in Clinical Remission at Month 2, 4, and 6
The proportion of subjects in clinical remission was defined as a score of 0 for rectal bleeding and 0 or 1 for stool frequency based on clinical response score component of the Clinical and Endoscopic Response Score. Clinical response score component had two subscales to assess subject's symptoms: rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes) and stool frequency ranging from 0 (normal number of stools) to 3 (>=5 stools more than normal). The scores of clinical response component ranged from 0 (normal) to 6 (severe disease), higher scores indicating greater disease severity. Data is presented cumulative for all pathways.
Time to Relapse
Time to relapse was defined as the number of days from randomization to the day of withdrawal due to escalation of therapy. Data is presented cumulative for all pathways.
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
The 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 were reported. 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.
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6
The adjusted mean change from baseline in serum CRP levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6
The adjusted mean change from baseline in fecal calprotectin levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6
The IBDQ is an instrument used to assess quality of life in adult subjects with ulcerative colitis. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Subjects were asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). The total IBDQ was computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better HRQOL. The adjusted mean change from baseline at Month 2, 4, and 6 for the IBDQ total scores were reported. Data is presented cumulative for all pathways.
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a subject participating in a clinical trial. Any AEs includes serious as well as non-serious AEs. An SAE is defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, or was an important medical event. Any AE which occurred in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit (Month 6) was considered treatment-emergent. Data is presented cumulative for all pathways.
Severity of Adverse Events
The number of subjects with intensity of AEs (classified as mild, moderate or severe) were presented. Data is presented cumulative for all pathways.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology
Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. Criteria for markedly abnormal laboratory (Hematology): Basophils/Leukocytes: >=5%, Eosinophils/Leukocytes: >=10%, Erythrocytes: <=3.5*10^6/μL, Hematocrit: <=0.32%; >=0.56%, Hemoglobin: <=11.5 g/dL, Leukocytes: <=2.8*10^3/μL; >=16.0*10^3/μL, Lymphocytes/Leukocytes: <=10%; >=80%, Monocytes/Leukocytes: >=20%, Neutrophils/Leukocytes: <=15%; >=90%, Platelets: <=75*10^3/μL; >=700*10^3/μL. Data is presented cumulative for all pathways.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation
Proportion of subjects with markedly abnormal changes from baseline in coagulation values are presented. Criteria for markedly abnormal laboratory (coagulation): Activated Partial Thromboplastin Time (aPTT): >70 seconds (sec), Prothrombin International Normalized Ratio (INR): <0.8; >1.1. Data is presented cumulative for all pathways.
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry
Proportion of subjects with markedly abnormal changes from baseline in serum chemistry values are presented. Criteria for markedly abnormal laboratory (serum chemistry): Alanine Aminotransferase (ALT): >3*upper limit of normal (ULN), Alkaline Phosphatase (ALP): >3*ULN and 25% increase (inc) from baseline (BL), Aspartate Aminotransferase (AST): >3* ULN, Bilirubin: >=1.5* ULN, Blood Urea Nitrogen: >=10.7 mg/dL, Calcium: <=1.8 mg/dL; >=3.9 mg/dL, Chloride: <=90 mmol/L; >=115 mmol/L, Creatinine: >=177 mg/dL, Gamma Glutamyl Transferase: >3*ULN, Glomerular Filtration Rate (GFR): <30 mL/min, Glucose: <=2.8 mg/dL; >=10 mg/dL, Potassium: <=3.0 mmol/L; >=5.8 mmol/L, Sodium: <=130 mmol/L; >=155 mmol/L. Data is presented cumulative for all pathways.

Full Information

First Posted
August 12, 2015
Last Updated
November 5, 2021
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02522780
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
September 19, 2018 (Actual)
Study Completion Date
September 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalamine
Arm Type
Experimental
Arm Description
Mesalamine 2 g extended release granules (sachet), administered orally once daily (QD) for 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matched to mesalamine extended release granules (sachet), administered orally QD for 6 months.
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Other Intervention Name(s)
Mesalazine, Pentasa
Intervention Description
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Primary Outcome Measure Information:
Title
Proportion of Subjects With Remission at Month 6
Description
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.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Proportion of Subjects in Clinical Remission at Month 2, 4, and 6
Description
The proportion of subjects in clinical remission was defined as a score of 0 for rectal bleeding and 0 or 1 for stool frequency based on clinical response score component of the Clinical and Endoscopic Response Score. Clinical response score component had two subscales to assess subject's symptoms: rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes) and stool frequency ranging from 0 (normal number of stools) to 3 (>=5 stools more than normal). The scores of clinical response component ranged from 0 (normal) to 6 (severe disease), higher scores indicating greater disease severity. Data is presented cumulative for all pathways.
Time Frame
Month 2, 4, and 6
Title
Time to Relapse
Description
Time to relapse was defined as the number of days from randomization to the day of withdrawal due to escalation of therapy. Data is presented cumulative for all pathways.
Time Frame
Time from randomization to the day of withdrawal due to escalation of therapy (up to 6 months)
Title
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
Description
The 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 were reported. 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.
Time Frame
Month 6
Title
Change From Baseline in Serum C-reactive Protein (CRP) Levels at Month 2, 4, and 6
Description
The adjusted mean change from baseline in serum CRP levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 2, 4, and 6
Title
Change From Baseline in Fecal Calprotectin Levels at Month 2, 4, and 6
Description
The adjusted mean change from baseline in fecal calprotectin levels at Month 2, 4, and 6 were reported. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 2, 4, and 6
Title
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Scores at Months 2, 4, and 6
Description
The IBDQ is an instrument used to assess quality of life in adult subjects with ulcerative colitis. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Subjects were asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). The total IBDQ was computed as the sum of the responses to the individual IBDQ questions. The total score can range between 32 to 224 with higher scores indicating a better HRQOL. The adjusted mean change from baseline at Month 2, 4, and 6 for the IBDQ total scores were reported. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 2, 4, and 6
Title
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE is defined as any untoward medical occurrence in a subject participating in a clinical trial. Any AEs includes serious as well as non-serious AEs. An SAE is defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, or was an important medical event. Any AE which occurred in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit (Month 6) was considered treatment-emergent. Data is presented cumulative for all pathways.
Time Frame
Up to Month 6
Title
Severity of Adverse Events
Description
The number of subjects with intensity of AEs (classified as mild, moderate or severe) were presented. Data is presented cumulative for all pathways.
Time Frame
Up to Month 6
Title
Proportion of Subjects With Markedly Abnormal Laboratory Values: Hematology
Description
Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. Criteria for markedly abnormal laboratory (Hematology): Basophils/Leukocytes: >=5%, Eosinophils/Leukocytes: >=10%, Erythrocytes: <=3.5*10^6/μL, Hematocrit: <=0.32%; >=0.56%, Hemoglobin: <=11.5 g/dL, Leukocytes: <=2.8*10^3/μL; >=16.0*10^3/μL, Lymphocytes/Leukocytes: <=10%; >=80%, Monocytes/Leukocytes: >=20%, Neutrophils/Leukocytes: <=15%; >=90%, Platelets: <=75*10^3/μL; >=700*10^3/μL. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 6
Title
Proportion of Subjects With Markedly Abnormal Laboratory Values: Coagulation
Description
Proportion of subjects with markedly abnormal changes from baseline in coagulation values are presented. Criteria for markedly abnormal laboratory (coagulation): Activated Partial Thromboplastin Time (aPTT): >70 seconds (sec), Prothrombin International Normalized Ratio (INR): <0.8; >1.1. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 6
Title
Proportion of Subjects With Markedly Abnormal Laboratory Values: Serum Chemistry
Description
Proportion of subjects with markedly abnormal changes from baseline in serum chemistry values are presented. Criteria for markedly abnormal laboratory (serum chemistry): Alanine Aminotransferase (ALT): >3*upper limit of normal (ULN), Alkaline Phosphatase (ALP): >3*ULN and 25% increase (inc) from baseline (BL), Aspartate Aminotransferase (AST): >3* ULN, Bilirubin: >=1.5* ULN, Blood Urea Nitrogen: >=10.7 mg/dL, Calcium: <=1.8 mg/dL; >=3.9 mg/dL, Chloride: <=90 mmol/L; >=115 mmol/L, Creatinine: >=177 mg/dL, Gamma Glutamyl Transferase: >3*ULN, Glomerular Filtration Rate (GFR): <30 mL/min, Glucose: <=2.8 mg/dL; >=10 mg/dL, Potassium: <=3.0 mmol/L; >=5.8 mmol/L, Sodium: <=130 mmol/L; >=155 mmol/L. Data is presented cumulative for all pathways.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Compliance
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
United Research Institute
City
Murrieta
State/Province
California
Country
United States
Facility Name
Research Associates of South Florida, LLC
City
Miami
State/Province
Florida
Country
United States
Facility Name
IMIC
City
Palmetto Bay
State/Province
Florida
Country
United States
Facility Name
Medical Research Center of Florida
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Lenus Research and Medical Group
City
Sweetwater
State/Province
Florida
Country
United States
Facility Name
Clinical Trials of SWLA, LLC
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
Wilmington Gastroenterology Associates
City
Wilmington
State/Province
North Carolina
Country
United States
Facility Name
Associates in Gastroenterology, PLC
City
Hermitage
State/Province
Tennessee
Country
United States
Facility Name
Quality Medical Research, PLLC
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Biopharma Informatic Inc.
City
Houston
State/Province
Texas
Country
United States
Facility Name
Digestive Health Center
City
Pasadena
State/Province
Texas
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
Country
United States
Facility Name
Digestive & Liver Disease Specialists
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Multiprofile Hospital For Active Treatment Avis Medica
City
Pleven
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Kaspela
City
Plovdiv
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD
City
Sevlievo
Country
Bulgaria
Facility Name
Medical Center-1-Sevlievo EOOD
City
Sevlievo
Country
Bulgaria
Facility Name
City Clinic University Multiprofile Hospital for Active Treatment EOOD
City
Sofia
Country
Bulgaria
Facility Name
Medical Center Asklepion - Humane Medicine Research EOOD
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
City
Sofia
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
City
Sofia
Country
Bulgaria
Facility Name
Diagnostic Consultative Centre Mladost M OOD
City
Varna
Country
Bulgaria
Facility Name
Topstone Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc
City
Toronto
State/Province
Vaughan
Country
Canada
Facility Name
Magyar Honvédség Egészségügyi Központ
City
Budapest
Country
Hungary
Facility Name
Pannónia Magánorvosi Centrum Kft
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem Institute
City
Budapest
Country
Hungary
Facility Name
Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja
City
Debrecen
Country
Hungary
Facility Name
ENDOMEDIX Kft.
City
Miskolc
Country
Hungary
Facility Name
Karolina Korhaz Rendelointezet
City
Mosonmagyarovar
Country
Hungary
Facility Name
Clinfan Kft.
City
Szekszard
Country
Hungary
Facility Name
Polana-D, LTD
City
Daugavpils
Country
Latvia
Facility Name
Digestive Diseases Centre Gastro
City
Riga
Country
Latvia
Facility Name
Latvian Maritime Medicine Centre
City
Riga
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Riga East Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
ICARO Investigaciones en Medicina, S.A de C.V
City
Chihuahua
Country
Mexico
Facility Name
Maria Auxiliadora Hospital
City
Guadalajara
Country
Mexico
Facility Name
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.
City
Zapopan
Country
Mexico
Facility Name
Osrodek Medycyny Rodzinnej Sp. z o.o.
City
Sobótka
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Lexmedica
City
Wroclaw
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Zespół Przychodni Specjalistycznych PRIMA Sp. z o.o.
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Intermed
City
Czestochowa
Country
Poland
Facility Name
Economicus - NZOZ ALL-MEDICUS
City
Katowice
Country
Poland
Facility Name
Investigational site
City
Ksawerow
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
City
Lodz
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
City
Lodz
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
Country
Poland
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka
City
Warsaw
Country
Poland
Facility Name
Regional Clinical Hospital
City
Krasnoyarsk
Country
Russian Federation
Facility Name
City Clinical Hospital # 51
City
Moscow
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Institute of Physiology of Sibirian Branch the RAMS
City
Novosibirsk
Country
Russian Federation
Facility Name
Omsk State Medical Academy
City
Omsk
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
Country
Russian Federation
Facility Name
State Budget Institution of Ryazan region" Regional Clinical Hospital"
City
Ryazan
Country
Russian Federation
Facility Name
City Hospital #31
City
Saint Petersburg
Country
Russian Federation
Facility Name
Russian Medical Military Academy n.a. S.M. Kirov
City
Saint Petersburg
Country
Russian Federation
Facility Name
Medical Company "Hepatolog", LLC
City
Samara
Country
Russian Federation
Facility Name
City Polyclinic #38
City
St. Petersburg
Country
Russian Federation
Facility Name
Stavropol State Medical Academy
City
Stavropol
Country
Russian Federation
Facility Name
Clinical Hospital Centar Zvezdara
City
Belgrade
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
Country
Serbia
Facility Name
Health Center Valjevo
City
Valjevo
Country
Serbia
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Investigational site
City
Bern
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
Country
Switzerland
Facility Name
Kyiv Municipal Clinical Hospital #18
City
Kyiv
State/Province
Kyïv
Country
Ukraine
Facility Name
Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv
City
Kyiv
State/Province
Kyïv
Country
Ukraine
Facility Name
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
City
Chernivtsi
Country
Ukraine
Facility Name
Municipal Institution Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnykov
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
City
Kharkiv
Country
Ukraine
Facility Name
SI National Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine
City
Kharkiv
Country
Ukraine
Facility Name
Municipal Intitution "Kherson City Clinical Hospital n.a. A. and O. Tropinykh"
City
Kherson
Country
Ukraine
Facility Name
Private Enterprise Private Manufactire Company "Acinus"
City
Kirovohrad
Country
Ukraine
Facility Name
Kremenchuk city Hospital # n.a O.T.Bohaievskyi
City
Kremenchuk
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #8
City
Kyiv
Country
Ukraine
Facility Name
Kyiv Municipal Clinical Hospital #18
City
Kyiv
Country
Ukraine
Facility Name
Medical Center Universal Clinic Oberih of LLC Kapytal
City
Kyiv
Country
Ukraine
Facility Name
Municipal City Clinical emergency Hospital
City
Lviv
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Clinical Hospital
City
Odesa
Country
Ukraine
Facility Name
Medical Clinical Research Center of Medical Center LLC Health Clinic
City
Vinnytsia
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov
City
Vinnytsia
Country
Ukraine
Facility Name
Small Business Private Enterprise Medical Center "Pulse"
City
Vinnytsya
Country
Ukraine
Facility Name
Municipal Institution 6th City Clinical Hospital of Zaporizhzhia City Council
City
Zaporizhzhia
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
Country
Ukraine
Facility Name
Medical Centre of PE First Private Clinic
City
Zhytomyr
Country
Ukraine

12. IPD Sharing Statement

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Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

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