Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522767
• Other study ID #: 000174
• Secondary ID: 2015-002557-35
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: April 3, 2018

Study information

• Verified date: February 2021
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: April 3, 2018
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Mesalamine

• Placebo

Locations

Country	Name	City	State
Bulgaria	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
Canada	Topstone Research Institute	Ottawa	Ontario
Canada	Toronto Digestive Disease Associates	Vaughan
Hungary	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	Mosonmagyarovar
Hungary	Clinfan Kft.	Szekszard
Latvia	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
Mexico	ICARO Investigaciones en Medicina, S.A de C.V	Chihuahua
Mexico	Maria Auxiliadora Hospital	Guadalajara
Mexico	Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V.	Zapopan
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Intermed	Czestochowa
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Economicus - NZOZ ALL-MEDICUS	Katowice
Poland	Investigational site	Ksawerow
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	Osrodek Medycyny Rodzinnej Sp. z o.o.	Sobótka	Dolnoslaskie
Poland	Investigational site	Sopot
Poland	Centrum Zdrowia Matki, Dziecka i Mlodziezy	Warsaw
Poland	Zespól Przychodni Specjalistycznych PRIMA Sp. z o.o.	Warszawa	Mazowieckie
Poland	Lexmedica	Wroclaw	Dolnoslaskie
Russian Federation	Regional Clinical Hospital	Krasnoyarsk
Russian Federation	City Clinical Hospital #51	Moscow
Russian Federation	Nizhegorodskaya Regional Clinical Hospital n.a. Semashko	Nizhny Novgorod
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	Research Institute of Physiology of Sibirian Branch the RAMS	Novosibirsk
Russian Federation	Omsk State Medical Academy	Omsk
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	State Budget Institution of Ryazan region" Regional Clinical Hospital"	Ryazan
Russian Federation	City Hospital #31	Saint Petersburg
Russian Federation	Russian Medical Military Academy n.a. S.M. Kirov	Saint Petersburg
Russian Federation	Railway Clinical Hospital at Station Samara OAO Rzhd	Samara
Russian Federation	City Polyclinic #38	St. Petersburg
Russian Federation	Stavropol State Medical Academy	Stavropol
Serbia	Clinical Hospital Centar Zvezdara	Belgrade
Serbia	Health Center Valjevo	Valjevo
Switzerland	Inselspital Bern	Bern
Switzerland	Investigational site	Bern
Switzerland	Universitätsspital Zürich	Zürich
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	Kyiv Municipal Clinical Hospital #18	Kyiv	Kyïv
Ukraine	Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv	Kyiv	Kyïv
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	Vinnytsia Regional Clinical Hospital Hospital n.a. M.I. Pyrohov	Vinnytsia
Ukraine	Small Business Private Enterprise Medical Center "Pulse"	Vinnytsya
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
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Associates in Gastroenterology, PLC	Hermitage	Tennessee
United States	BI Research Center	Houston	Texas
United States	Biopharma Informatic Inc.	Houston	Texas
United States	Clinical Trials of SWLA, LLC	Lake Charles	Louisiana
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Research Associates of South Florida, LLC	Miami	Florida
United States	United Research Institute	Murrieta	California
United States	Quality Medical Research, PLLC	Nashville	Tennessee
United States	Digestive & Liver Disease Specialists	Norfolk	Virginia
United States	Advanced Research Institute	Ogden	Utah
United States	IMIC	Palmetto Bay	Florida
United States	Digestive Health Center	Pasadena	Texas
United States	Medical Research Center of Florida	Pembroke Pines	Florida
United States	Lenus Research and Medical Group	Sweetwater	Florida
United States	DM Clinical Research	Tomball	Texas
United States	Wilmington Gastroenterology Associates	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Latvia,  Mexico,  Poland,  Russian Federation,  Serbia,  Switzerland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At Week 8
Secondary	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.	Up to Week 8
Secondary	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.	At Week 8
Secondary	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.	At Week 2, 4, and 8
Secondary	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.	Up to Week 8
Secondary	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.	From baseline to Week 2, 4, and 8
Secondary	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.	From baseline to Week 2, 4, and 8
Secondary	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.	From baseline to Week 8
Secondary	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).	From baseline to Week 2, 4, and 8
Secondary	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.	Up to Week 16
Secondary	Severity of Adverse Events	The proportion of subjects with intensity of AEs (classified as mild, moderate or severe) are presented.	Up to Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16
Secondary	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.	Up to Week 16