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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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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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PubMed Articles [923 Associated PubMed Articles listed on BioPortfolio]

Mesalazine: A Novel Etiology For Drug-Induced Urinary Calculi.

We report the case of a 23-year-old woman treated by mesalazine for ulcerative colitis and who subsequently presented recurrent renal colic due to mesalazine urinary stones. This is the second case de...

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Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis.

A bio-predictive in vitro comparison of oral locally-acting mesalazine formulations by a novel dissolution model for assessing intraluminal drug release in individual subjects.

Drug release and availability at the site of action are the major factors determining the clinical response for locally-acting gastrointestinal (GI) drug products. The present work focused on the pred...

Adherence to a Healthy Lifestyle is Associated With a Lower Risk of Diverticulitis among Men.

Diverticulitis is a common disease with high clinical burden. We evaluated the joint contribution of multiple lifestyle factors to risks of incident diverticulitis. We also estimated the proportion of...

Effectiveness of Mesalazine, Thiopurines and Tumour Necrosis Factor Antagonists in Preventing Post-Operative Crohn's Disease Recurrence in a Real-Life Setting.

Most Crohn's disease (CD) patients develop endoscopic recurrence within one year of intestinal resection. The best treatment method to prevent post-operative CD recurrence remains uncertain.

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.

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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