Mesalazine

Generic Name
Mesalazine
Brand Names
Apriso, Asacol, Canasa, Delzicol, Lialda, Mezavant, Pentasa, Rowasa, Salofalk, Zaldyon
Drug Type
Small Molecule
Chemical Formula
C7H7NO3
CAS Number
89-57-6
Unique Ingredient Identifier
4Q81I59GXC
Background

An anti-inflammatory agent, structurally related to the salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid, which is active in inflammatory bowel disease . Although demonstrably effective in treating and maintaining remission for ulcerative colitis, mesalazine has historically faced a number of issues regarding its lack of stability as a pharmaceutical agent . Throughout the late seventies and the eighties, important research initiatives developed stable mesalazine formulations like the eudragit-S coating of Asacol brand mesalazine and the Pentasa brand's encapsulation of mesalazine within microgranules . In the present day, contemporary research regarding novel methods to stabilize mesalazine continues and interest in the agent's capacity to decrease inflammatory activity and subsequently potentially reduce the risk of colorectal cancer in conditions like ulcerative colitis is maintained.

Indication

适用于溃疡性结肠炎和克罗恩病(Crohn病)。

Associated Conditions
Acute Ulcerative Colitis, Crohn's Disease Relapse, Crohn's Ileocolitis, Mild to Moderate Ulcerative Colitis, Proctitis, Proctitis, Ulcerative, Proctosigmoiditis, Ulcerative Colitis in Remission, Mild Ulcerative Colitis, Mild to moderate distal ulcerative colitis, Moderate Ulcerative colitis
Associated Therapies
-

Asacol Acute Diverticulitis(DIVA)Study

First Posted Date
2007-11-06
Last Posted Date
2013-04-22
Lead Sponsor
Warner Chilcott
Target Recruit Count
117
Registration Number
NCT00554099
Locations
🇺🇸

Research Facility, Monroe, Wisconsin, United States

🇺🇸

Research Site, Chesapeake, Virginia, United States

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Phase 3
Completed
Conditions
First Posted Date
2007-10-24
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
343
Registration Number
NCT00548574
Locations
🇧🇪

Imelda General Hospital Dept of Gastroenterology, Bonheiden, Belgium

Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome

First Posted Date
2007-08-10
Last Posted Date
2017-07-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Registration Number
NCT00514982
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Phase 3
Completed
Conditions
First Posted Date
2007-03-21
Last Posted Date
2016-01-21
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
380
Registration Number
NCT00449722
Locations
🇩🇪

Evangelisches Krankenhaus Kalk, Cologne, Germany

Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

First Posted Date
2007-03-21
Last Posted Date
2014-05-19
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
92
Registration Number
NCT00450086
Locations
🇩🇪

Center of digestive diseases, Hamburg, Germany

A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-07-10
Last Posted Date
2013-04-17
Lead Sponsor
Warner Chilcott
Target Recruit Count
772
Registration Number
NCT00350415
Locations
🇺🇦

Research Facility, Zaporizhzhya, Ukraine

🇱🇹

Research FacilityPanevezys, Panevezys, Lithuania

Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2006-07-07
Last Posted Date
2019-01-29
Lead Sponsor
Annette Langseder
Target Recruit Count
1
Registration Number
NCT00349388
Locations
🇺🇸

Morristown Memorial Hospital/Goyerb Children's Hospital, Morristown, New Jersey, United States

Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-03-08
Last Posted Date
2014-05-19
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
311
Registration Number
NCT00300118
Locations
🇩🇪

Ev. Krankenhaus Hattingen GmbH, Hattingen, Germany

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2005-11-16
Last Posted Date
2013-04-17
Lead Sponsor
Warner Chilcott
Target Recruit Count
34
Registration Number
NCT00254618
Locations
🇺🇸

Research Site, Seattle, Washington, United States

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2011-05-19
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
362
Registration Number
NCT00209300
Locations
🇧🇪

UZ Gent, Gent, Belgium

🇧🇪

Heilig Hart Ziekenhuis, Roeselaere, Belgium

🇨🇿

Gastroenterologie MUDr.V.Abrahámová, Poděbrady, Czech Republic

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