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Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate 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
  • 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

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
  • 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
  • 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
  • Investigational site
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • 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
  • State Budget Institution of Ryazan region" Regional Clinical Hospital"
  • City Hospital #31
  • Russian Medical Military Academy n.a. S.M. Kirov
  • Railway Clinical Hospital at Station Samara OAO Rzhd
  • City Polyclinic #38
  • Stavropol State Medical Academy
  • Clinical Hospital Centar Zvezdara
  • 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

4 g extended release granules (sachet)

Matching placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal [score=0], mild disease [score=1], moderate disease [score=2], severe disease [score=3]). The statistical test was to be conducted only if the primary analysis was significant.
Time to Cessation of Rectal Bleeding
Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary. The statistical test was to be conducted only if the primary analysis was significant.
The Proportion of Subjects With Endoscopic Improvement
Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.
The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.
Time to Normal Stool Pattern
Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.
The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8
Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.
The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8
The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.
The Change From Baseline in Fecal Calprotectin Levels at Week 8
The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.
The Change From Baseline in Health Related Quality of Life (QoL) Scores
The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores. The adjusted changes from baseline and their differences between treatment groups are presented. The IBDQ is an instrument used to assess quality of life in adult patients with UC. Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).
Number of Participants Experiencing Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial. A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit. Proportion of subjects with any TEAE (serious or non-serious) are presented.
Severity of Adverse Events
The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.
Proportion of Subject With Abnormal Laboratory Values (Hematology)
Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. >= greater than equal to; <= less than equal to.
Proportion of Subjects With Abnormal Laboratory Values (Coagulation)
Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented. INR= International normalized ratio.
Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented. ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.

Full Information

First Posted
August 12, 2015
Last Updated
February 19, 2021
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02522767
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
April 3, 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 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.

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
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalamine
Arm Type
Experimental
Arm Description
4 g extended release granules (sachet)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Other Intervention Name(s)
Mesalazine, Pentasa
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of Subjects With Remission
Description
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).
Time Frame
At Week 8
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Remission in the Primary Endpoint and the Physician's Global Assessment (PGA) Score of ≤1 (Modified Mayo Score)
Description
The Modified Mayo score was calculated as the sum of the Clinical and Endoscopic Response Score (Range: 0-9, and the standard PGA score (range: 0-3; normal [score=0], mild disease [score=1], moderate disease [score=2], severe disease [score=3]). The statistical test was to be conducted only if the primary analysis was significant.
Time Frame
At Week 8
Title
Time to Cessation of Rectal Bleeding
Description
Defined as time in days from randomization to the first day of 3 consecutive days with a rectal bleeding score of 0, based on subject's daily diary. The statistical test was to be conducted only if the primary analysis was significant.
Time Frame
Up to Week 8
Title
The Proportion of Subjects With Endoscopic Improvement
Description
Defined as an Endoscopic Response Score of 0 or 1, with at least a 1 point reduction from baseline in the endoscopic score at Week 8.
Time Frame
At Week 8
Title
The Proportion of Subjects in Clinical Remission at Weeks 2, 4, and 8
Description
Defined as a score of 0 for rectal bleeding and 0 or 1 with at least 1 point decrease from baseline for stool frequency in the Clinical Response Score subset.
Time Frame
At Week 2, 4, and 8
Title
Time to Normal Stool Pattern
Description
Defined as time in days from randomization to the first day of 3 consecutive days with a stool frequency score of 0, based on subject daily diary.
Time Frame
Up to Week 8
Title
The Change From Baseline in Rectal Bleeding Score at Weeks 2, 4, and 8
Description
Defined as change from baseline in rectal bleeding score at Week 2, 4, and 8 based on subject daily diary. Rectal Bleeding Score is graded 0-3, where 0 is best.
Time Frame
From baseline to Week 2, 4, and 8
Title
The Change From Baseline in Serum C-reactive Protein (CRP) Levels at Weeks 2, 4, and 8
Description
The adjusted mean changes in serum CRP levels from baseline and their difference between treatment groups are presented for each time point.
Time Frame
From baseline to Week 2, 4, and 8
Title
The Change From Baseline in Fecal Calprotectin Levels at Week 8
Description
The adjusted mean change from baseline in fecal calprotectin levels at Week 8 are presented.
Time Frame
From baseline to Week 8
Title
The Change From Baseline in Health Related Quality of Life (QoL) Scores
Description
The change from baseline to Week 2, 4, and 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) scores. The adjusted changes from baseline and their differences between treatment groups are presented. The IBDQ is an instrument used to assess quality of life in adult patients with UC. Subjects were asked to recall symptoms and QoL from last two weeks and to rate each item on a 7- point Likert score (higher scores equate to higher QoL).
Time Frame
From baseline to Week 2, 4, and 8
Title
Number of Participants Experiencing Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in a clinical trial. A 'treatment-emergent AE (TEAE)' is defined as an AE which occurs in the time interval from initial dosing (investigational medicinal product [IMP] intake) to the end of treatment visit. Proportion of subjects with any TEAE (serious or non-serious) are presented.
Time Frame
Up to Week 16
Title
Severity of Adverse Events
Description
The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.
Time Frame
Up to Week 16
Title
Proportion of Subject With Abnormal Laboratory Values (Hematology)
Description
Proportion of subjects with markedly abnormal changes from baseline in hematology values are presented. >= greater than equal to; <= less than equal to.
Time Frame
Up to Week 16
Title
Proportion of Subjects With Abnormal Laboratory Values (Coagulation)
Description
Proportion of subjects with markedly abnormal changes from baseline values in coagulation laboratory values are presented. INR= International normalized ratio.
Time Frame
Up to Week 16
Title
Proportion of Subjects With Abnormal Laboratory Values (Serum Chemistry)
Description
Proportion of subjects with markedly abnormal changes in serum chemistry laboratory values are presented. ALT= Alanine aminotransferase; AST= Aspartate aminotransferase; BUN= Blood urea nitrogen; GGT= Gamma glutamyl transferase.
Time Frame
Up to Week 16

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 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
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
ZIP/Postal Code
37076
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
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
City
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
Investigational site
City
Sopot
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
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
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
Railway Clinical Hospital at Station Samara OAO Rzhd
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
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 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

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