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 stabil...

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
-
Clinical Trials
Related News

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

First Posted Date
2008-12-16
Last Posted Date
2010-11-17
Lead Sponsor
Palau Pharma S.L.U.
Target Recruit Count
80
Registration Number
NCT00808977
Locations
🇸🇰

Investigational site 18, Košice, Slovakia

🇧🇪

Investigational site 11, Kortrijk, Belgium

🇭🇺

Investigational site 10, Eger, Hungary

and more 19 locations

Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

Not Applicable
Completed
Conditions
Healthy
Interventions
Drug: Mesalamine
First Posted Date
2008-12-05
Last Posted Date
2021-10-15
Lead Sponsor
Padagis LLC
Target Recruit Count
48
Registration Number
NCT00802451

A Randomized Controlled Pilot Trial of Mesalazine in Patients With Irritable Bowel Syndrome

Phase 2
Completed
Conditions
Irritable Bowel Syndrome
Interventions
Drug: placebo
Drug: mesalazine
First Posted Date
2008-10-16
Last Posted Date
2008-10-16
Lead Sponsor
SOFAR S.p.A.
Target Recruit Count
20
Registration Number
NCT00774007
Locations
🇮🇹

Department of Internal Medicine & Gastroenterology, Bologna, Italy

Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Asacol
Drug: Lialda
First Posted Date
2008-09-12
Last Posted Date
2013-04-17
Lead Sponsor
Warner Chilcott
Target Recruit Count
37
Registration Number
NCT00751699
Locations
🇺🇸

Research Site, Miami, Florida, United States

Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)

Phase 3
Completed
Conditions
Colitis, Ulcerative
Interventions
Drug: budesonide
Drug: mesalazine
First Posted Date
2008-09-04
Last Posted Date
2012-06-26
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
343
Registration Number
NCT00747110
Locations
🇩🇪

Klinikum St. Marien, Amberg, Germany

Mesalazine Granules vs. Placebo for the Prevention of Recurrence of Diverticulitis

Phase 3
Terminated
Conditions
Diverticulitis
Interventions
Drug: Placebo
Drug: Mesalazine
First Posted Date
2008-06-12
Last Posted Date
2017-07-24
Lead Sponsor
Dr. Falk Pharma GmbH
Target Recruit Count
345
Registration Number
NCT00695643
Locations
🇩🇪

Evang. Krankenhaus Kalk, Medical department, Cologne, Germany

Dose Escalation and Remission (DEAR)

Phase 4
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: mesalamine
First Posted Date
2008-04-03
Last Posted Date
2015-05-05
Lead Sponsor
James Lewis
Target Recruit Count
119
Registration Number
NCT00652145
Locations
🇺🇸

Shafran Gastroenterology Center, Winter Park, Florida, United States

🇺🇸

Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

🇺🇸

Minnesota Gastroenterology, P.A., Plymouth, Minnesota, United States

and more 5 locations

Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Phase 3
Completed
Conditions
Irritable Bowel Syndrome
Interventions
Drug: Placebo
Drug: Mesalazine
First Posted Date
2008-02-29
Last Posted Date
2013-07-26
Lead Sponsor
SOFAR S.p.A.
Target Recruit Count
187
Registration Number
NCT00626288
Locations
🇮🇹

Ospedale SS. Annunziata, Chieti, Italy

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Opera Padre Pio, Foggia, Italy

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Azienda Ospedaliera Polo Universitario L.Sacco, Milano, Italy

and more 19 locations

PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: mesalamine
First Posted Date
2008-02-25
Last Posted Date
2019-11-18
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
24
Registration Number
NCT00622375

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Phase 3
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: mesalamine
First Posted Date
2007-12-20
Last Posted Date
2011-09-16
Lead Sponsor
Warner Chilcott
Target Recruit Count
301
Registration Number
NCT00577473
Locations
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Research Site, Milwaukee, Wisconsin, United States

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Research Facility, Falls Church, Virginia, United States

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