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

2014-08-27 03:17:04 | BioPortfolio

Summary

The purpose of the study is to determine which dose of mesalazine granules compared to placebo is more effective in the prevention of recurrence of disease.

Description

The primary purpose of the study is to demonstrate the superiority of mesalazine granules compared to placebo in terms of the two primary efficacy variables 'proportion of recurrence-free patients within 48 weeks' and 'proportion of recurrence-free patients within 96 weeks'.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Diverticulitis

Intervention

Mesalazine, Mesalazine, Placebo

Location

United Medical Research
New Smyrna Beach
Florida
United States
32168

Status

Recruiting

Source

Dr. Falk Pharma GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:04-0400

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

The purpose of the study is to determine whether mesalazine granules compared to placebo is effective in prevention of recurrence of disease.

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Prevention of Recurrence of Diverticulitis

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Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.

The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2...

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This study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic r...

PubMed Articles [929 Associated PubMed Articles listed on BioPortfolio]

Mesalazine to treat symptomatic uncomplicated diverticular disease and to prevent acute diverticulitis occurrence. A systematic review with meta-analysis of randomized, placebo-controlled trials.

Symptomatic Uncomplicated Diverticular disease (SUDD) affects about 25% of patients harboring colonic diverticula. We assessed the effectiveness of mesalazine in improving symptoms (namely abdominal p...

Mesalazine, an osteopontin inhibitor: The potential prophylactic and remedial roles in induced liver fibrosis in rats.

Liver fibrosis is a major health issue leading to high morbidity and mortality. The potential anti-fibrotic activity and the effect of mesalazine on osteopontin (OPN), an extra cellular matrix (ECM) c...

Treatment of diverticular disease, targeting symptoms or underlying mechanisms.

Diverticular disease (DD) is a highly prevalent disease in western industrialized countries that encompasses a complex set of disorders. Because of its complexity and heterogeneity, both from a pathog...

Changing theories on the pathogenesis and risk factors for diverticulitis.

Diverticulitis was thought to be a simple complication of an even simpler disease (diverticulosis), but may in fact result from an entirely new set of complex pathologies. Considering diverticulitis i...

Management of acute uncomplicated diverticulitis without antibiotics: a systematic review, meta-analysis, and meta-regression of predictors of treatment failure.

Diverticulitis is a common complication of diverticular disease of the colon. While complicated diverticulitis often warrants intervention, acute uncomplicated diverticulitis (AUD) is usually managed ...

Medical and Biotech [MESH] Definitions

Inflammation of a DIVERTICULUM or diverticula.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Diseases of the DIVERTICULUM often due to infection and/or inflammation (DIVERTICULITIS).

Inflammation of the COLONIC DIVERTICULA, generally with abscess formation and subsequent perforation.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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