Mesalazine

Generic Name: Mesalazine

Brand Names: Apriso, Asacol, Canasa, Delzicol, Lialda, Mezavant, Pentasa, Rowasa, Salofalk, Zaldyon

Drug Type: Small Molecule

Chemical Formula: C_₇H_₇NO_₃

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

Clinical Trial With Mesalamine 1g Suppositories

Phase 3

Terminated

Conditions: Proctitis

Interventions: Drug: Mesalamine
Drug: Canasa
Drug: Placebo

First Posted Date: 2010-07-29

Last Posted Date: 2017-03-27

Lead Sponsor: Sandoz

Target Recruit Count: 158

Registration Number: NCT01172444

Locations: 🇮🇳
Dr. Nijhawan's Clinic, Jaipur, Rajasthan, India
🇮🇳
Kala Endoscopy & Liver Clinic, Jodhpur, Rajasthan, India
🇮🇳
Sharma Gastroenterology Centre, Jaipur, Rajasthan, India

and more 35 locations

Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

Phase 3

Completed

Conditions: Diverticular Disease

Interventions: Drug: mesalamine
Other: placebo

First Posted Date: 2010-05-10

Last Posted Date: 2013-09-18

Lead Sponsor: SOFAR S.p.A.

Target Recruit Count: 105

Registration Number: NCT01120340

Locations: 🇮🇹
Ospedale Maggiore, Crema, Cremona, Italy
🇮🇹
Ospedale di Garbagnate M.se, Garbagnate Milanese, Milano, Italy
🇮🇹
Ospedale C. Borella, Giussano, Milano, Italy

and more 14 locations

Targeting Oxidative Stress in Chronic Beryllium Disease

Phase 1

Completed

Conditions: Chronic Beryllium Disease

Interventions: Drug: Placebo
Drug: Mesalamine

First Posted Date: 2010-03-17

Last Posted Date: 2018-10-12

Lead Sponsor: National Jewish Health

Target Recruit Count: 18

Registration Number: NCT01088243

Locations: 🇺🇸
National Jewish Health, Denver, Colorado, United States

A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

Phase 3

Completed

Conditions: Mild to Moderate Ulcerative Colitis

Interventions: Drug: Placebo
Drug: Mesalamine

First Posted Date: 2010-01-08

Last Posted Date: 2010-01-08

Lead Sponsor: EMET Pharmaceuticals, LLC

Registration Number: NCT01045018

Two Doses Mesalazine Granules Versus Placebo for the Prevention of Recurrence of Diverticulitis

Phase 3

Terminated

Conditions: Diverticulitis

Interventions: Drug: Placebo
Drug: Mesalazine

First Posted Date: 2009-12-24

Last Posted Date: 2017-07-21

Lead Sponsor: Dr. Falk Pharma GmbH

Target Recruit Count: 330

Registration Number: NCT01038739

Locations: 🇺🇸
United Medical Research, New Smyrna Beach, Florida, United States

Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

Phase 1

Completed

Conditions: Ulcerative Colitis

Interventions: Drug: mesalamine

First Posted Date: 2009-11-24

Last Posted Date: 2011-03-29

Lead Sponsor: Altheus Therapeutics, Inc.

Target Recruit Count: 9

Registration Number: NCT01020708

Locations: 🇺🇸
Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma, United States

Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

Phase 3

Terminated

Conditions: Colitis, Ulcerative

Interventions: Biological: Infliximab
Drug: Prednisolone
Drug: Azathioprine
Drug: 5-aminosalicylic acid

First Posted Date: 2009-09-25

Last Posted Date: 2017-04-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 28

Registration Number: NCT00984568

Trial of Mesalamine for the Treatment of Active Microscopic Colitis

Phase 2

Completed

Conditions: Microscopic Colitis
Diarrhea

First Posted Date: 2009-08-06

Last Posted Date: 2011-05-24

Lead Sponsor: Mayo Clinic

Target Recruit Count: 70

Registration Number: NCT00952952

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Mesalazine
Drug: Azathioprine
Drug: Mesalazine placebo
Drug: Azathioprine placebo

First Posted Date: 2009-07-27

Last Posted Date: 2012-06-26

Lead Sponsor: Dr. Falk Pharma GmbH

Target Recruit Count: 78

Registration Number: NCT00946946

Locations: 🇩🇪
Robert-Bosch Krankenhaus, Innere Medizin I, Stuttgart, Germany
🇦🇹
Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria

A Study With Pentasa in Patients With Active Crohn's Disease

Phase 3

Terminated

Conditions: Crohn´s Disease

Interventions: Drug: Pentasa
Drug: Placebo

First Posted Date: 2009-03-16

Last Posted Date: 2012-03-16

Lead Sponsor: Ferring Pharmaceuticals

Target Recruit Count: 20

Registration Number: NCT00862121

Locations: 🇺🇸
Clinical Research of West Florida, Clearwater, Florida, United States
🇺🇸
Center for Digestive and Liver Disease, Inc, Mexico, Montana, United States
🇩🇪
Gemeinschaftspraxis, Leipzig, Germany

and more 11 locations

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