Trial reportGut2009
Once daily versus three times daily mesalazine granules in active ulcerative colitis: a double-blind, double-dummy, randomised, non-inferiority trial.
Trial report in Gut, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00449722 (Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis), which is not on this map. Cited by 54 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules Versus Three Times Daily 1.0 g Mesalazine Granules in Patients With Active Ulcerative Colitis
Who cites it
54 citing papers in PubMed, 5 syntheses or guidelines pooled it, 202 citations in OpenAlex.
- 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 induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Histologic scoring indices for evaluation of disease activity in ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Histological Disease Activity as a Predictor of Clinical Relapse Among Patients With Ulcerative Colitis: Systematic Review and Meta-Analysis.The American journal of gastroenterology · 2016Pooled it
- Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016Pooled it
- The Effectiveness of Patient Training in Inflammatory Bowel Disease Knowledge via Instagram: Randomized Controlled Trial.Journal of medical Internet research · 2022Trial
- Clinical trial: Effects of an oral preparation of mesalazine at 4 g/day on moderately active ulcerative colitis. A phase III parallel-dosing study.Journal of gastroenterology · 2011Trial
- Switching from sulphasalazine or oral 5-aminosalicylic acid to another oral 5-aminosalicylic acid drug in the maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2026Article
- Article
- Prospective Questionnaire Survey on Adherence to Oral 5-Aminosalicylic Acid in Patients With Ulcerative Colitis.JGH open : an open access journal of gastroenterology and hepatology · 2025Article
- Medication Non-Adherence in Inflammatory Bowel Disease: A Systematic Review Identifying Risk Factors and Opportunities for Intervention.Pharmacy (Basel, Switzerland) · 2025Review
- Exploring the relationship betweenComputational and structural biotechnology journal · 2024Review
- Nanoparticle-Based Drug Delivery Systems for Inflammatory Bowel Disease Treatment.Drug design, development and therapy · 2024Review
- Treatment of Patients with Mild to Moderate Ulcerative Colitis: A Middle East Expert Consensus.Journal of clinical medicine · 2023Review
- Mesalazine granules promote disease clearance in patients with mild-to-moderate ulcerative colitis.United European gastroenterology journal · 2023Article
- Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α.The Korean journal of internal medicine · 2022Review
- Patient Preference and Adherence to Aminosalicylates for the Treatment of Ulcerative Colitis.Clinical and experimental gastroenterology · 2021Review
- Article
- Intrarectally administered polaprezinc attenuates the development of dextran sodium sulfate-induced ulcerative colitis in mice.Experimental and therapeutic medicine · 2019Article
- Adherence to Asacol once daily versus divided regimen for maintenance therapy in ulcerative colitis: a prospective, multicenter, randomized study.Intestinal research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo determine the therapeutic equivalence and safety of once daily (OD) versus three times daily (TID) dosing of a total daily dose of 3 g Salofalk (mesalazine) granules in patients with active ulcerative colitis.
designA randomised, double-blind, double-dummy, parallel group, multicentre, international, phase III non-inferiority study.
setting54 centres in 13 countries. PATIENTS: 380 patients with confirmed diagnosis of established or first attack of ulcerative colitis (clinical activity index (CAI)>4 and endoscopic index > or =4 at baseline) were randomised and treated.
interventions8-week treatment with either 3 g OD or 1 g TID mesalazine granules.
main outcome measuresClinical remission (CAI< or =4) at study end.
results380 patients were evaluable for efficacy and safety by intention-to-treat (ITT); 345 for per protocol (PP) analysis. In the ITT population, 79.1% in the OD group (n = 191) and 75.7% in the TID group (n = 189) achieved clinical remission (p<0.0001 for non-inferiority). Significantly more patients with proctosigmoiditis achieved clinical remission in the OD group (86%; n = 97) versus the TID group (73%; n = 100; p = 0.0298). About 70% of patients in both treatment groups achieved endoscopic remission, and 35% in the OD group and 41% in the TID group achieved histological remission. About 80% of all patients preferred OD dosing. Similar numbers of adverse events occurred in 55 patients (28.8%) in the OD group and in 61 patients (32.3%) in the TID group, indicating that the two dosing regimens were equally safe and well tolerated.
conclusionsOD 3 g mesalazine granules are as effective and safe as a TID 1 g schedule. With respect to the best possible adherence of patients to the treatment, OD dosing of mesalazine should be the preferred application mode in active ulcerative colitis.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.