Next Article in Journal
Osteopontin Gene Polymorphism and Urinary OPN Excretion in Patients with Immunoglobulin A Nephropathy
Next Article in Special Issue
Molecular Profiling of Inflammatory Bowel Disease: Is It Ready for Use in Clinical Decision-Making?
Previous Article in Journal
Pharmacogenetic-Based Interactions between Nutraceuticals and Angiogenesis Inhibitors
Previous Article in Special Issue
Pre-Treatment Biomarkers of Anti-Tumour Necrosis Factor Therapy Response in Crohn’s Disease—A Systematic Review and Gene Ontology Analysis
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Cells
Volume 8
Issue 6
10.3390/cells8060523
cells-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis

by
Gionata Fiorino
1,2,
Giacomo Carlo Sturniolo
3,
Fabrizio Bossa
4,
Andrea Cassinotti
5,
Antonio Di Sabatino
6,
Paolo Giuffrida
6 and
Silvio Danese
1,2,*
1
Division of Gastroenterology, IBD Center, Humanitas Clinical and Research Center, 20089 Milan, Italy
2
Department of Biomedical Sciences, Humanitas University, 20090 Milan, Italy
3
Azienda Ospedaliera di Padova, 35128 Padova, Italy
4
Fondazione Casa Sollievo della Sofferenza IRCCS—Gastroenterology Department, 71013 Foggia, Italy
5
UOC Gastroenterologia, ASST Fatebenefratelli Sacco, Luigi Sacco University Hospital, 20157 Milano, Italy
6
Dipartimento Area Medica S.C. Medicina Generali, IRCCS Policlinico San Matteo, 27100 Pavia, Italy
*
Author to whom correspondence should be addressed.
Cells 2019, 8(6), 523; https://doi.org/10.3390/cells8060523
Submission received: 15 April 2019 / Revised: 23 May 2019 / Accepted: 23 May 2019 / Published: 30 May 2019
(This article belongs to the Special Issue The Molecular and Cellular Basis for Inflammatory Bowel Diseases (IBD))
Browse Figure
Versions Notes

Abstract

IBD98-M is a delayed-release formulation of mesalamine (mesalazine) and SH with a potential therapeutic role in ulcerative colitis (UC). A total of 51 patients with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of ≥4 and ≤10, and a modified UCDAI endoscopy subscore ≥1 were randomized for 6 weeks of double-blind treatment with IBD98 0.8 g/day or IBD 1.2 g/day or placebo. The efficacy and safety of IBD98-M in mild to moderate active UC were primarily evaluated. At week 6, 1 (5.9%), 2 (12.5%), and 2 (11.1%) patients receiving IBD98-M 0.8 g, IBD98-M 1.2 g, and placebo, respectively, (p > 0.999) achieved clinical remission. Higher clinical response was seen in IBD98-M 1.2 g (31.3%) versus placebo (16.7%) and endoscopic improvement in IBD98-M 0.8 g (29.4%) versus placebo (22.2%) was seen. Fecal calprotectin levels were reduced in IBD98-M groups versus placebo (p > 0.05). IBD98-M patients achieved significant improvement in physical health summary score component of the SF-36 (p = 0.01 and p = 0.03 respectively) compared to placebo. IBD98-M did not meet the primary end point but had higher clinical response (1.2 g/day) and endoscopic improvement (0.8 g/day) compared to placebo. The safety result shown that IBD98-M treatment was safe and well tolerated in this patient population. No new safety signals or unexpected safety findings were observed during the study. Further trials with different stratification and longer follow-up may be needed to evaluate the efficacy.
Keywords: IBD98-M; sodium hyaluronate; mesalazine; mesalamine; 5-ASA; ulcerative colitis; inflammatory bowel disease IBD98-M; sodium hyaluronate; mesalazine; mesalamine; 5-ASA; ulcerative colitis; inflammatory bowel disease

Share and Cite

MDPI and ACS Style

Fiorino, G.; Sturniolo, G.C.; Bossa, F.; Cassinotti, A.; Di Sabatino, A.; Giuffrida, P.; Danese, S. A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis. Cells 2019, 8, 523. https://doi.org/10.3390/cells8060523

AMA Style

Fiorino G, Sturniolo GC, Bossa F, Cassinotti A, Di Sabatino A, Giuffrida P, Danese S. A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis. Cells. 2019; 8(6):523. https://doi.org/10.3390/cells8060523

Chicago/Turabian Style

Fiorino, Gionata, Giacomo Carlo Sturniolo, Fabrizio Bossa, Andrea Cassinotti, Antonio Di Sabatino, Paolo Giuffrida, and Silvio Danese. 2019. "A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis" Cells 8, no. 6: 523. https://doi.org/10.3390/cells8060523

APA Style

Fiorino, G., Sturniolo, G. C., Bossa, F., Cassinotti, A., Di Sabatino, A., Giuffrida, P., & Danese, S. (2019). A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis. Cells, 8(6), 523. https://doi.org/10.3390/cells8060523

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop