ArticleUnited European gastroenterology journal2018
Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial.
Article in United European gastroenterology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Definition of mild to moderate ulcerative colitis in clinical trials: A systematic literature review.United European gastroenterology journal · 2022Pooled it
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Article
- Non-Adherence Rate to Oral Mesalamine in Ulcerative Colitis Patients: A Systematic Review with Meta-Analysis.Journal of personalized medicine · 2025Review
- An In Vitro Study Evaluating the Safety of Mesalazine on Human Nasoepithelial Cells.International journal of molecular sciences · 2024Article
- Mesalazine granules promote disease clearance in patients with mild-to-moderate ulcerative colitis.United European gastroenterology journal · 2023Article
- The neglected biliary mucus and its phosphatidylcholine content: a putative player in pathogenesis of primary cholangitis-a narrative review article.Annals of translational medicine · 2021Review
- Moving from efficacy to effectiveness: budesonide multimatrix in ulcerative colitis.United European gastroenterology journal · 2019Article
- Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis.
objectiveThe objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission.
methodsThis pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis. The primary efficacy variable was clinical remission at week 8.
resultsA total of 306 patients were considered for intent-to-treat analysis. Clinical remission was achieved in 45.0% of the patients in the M1000 group versus 41.9% in the M2x500 group (
conclusionsThe novel high-dose 1000 mg mesalazine tablet is effective, non-inferior to the registered 500 mg mesalazine tablet, and safe for ulcerative colitis treatment. It was preferred by a majority of patients and may improve ulcerative colitis treatment adherence.
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Registered trials
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