Trial reportGut2008
Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis.
Trial report in Gut, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00151944 (A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476), which is not on this map. Cited by 49 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.
A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission.
Who cites it
49 citing papers in PubMed, 5 syntheses or guidelines pooled it, 175 citations in OpenAlex.
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2016Pooled it
- Indian Society of Gastroenterology consensus on ulcerative colitis.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2012Guideline
- Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Maintenance Outcomes: the MOMENTUM Trial.Journal of Crohn's & colitis · 2016Trial
- Trial
- One-year investigator-blind randomized multicenter trial comparing Asacol 2.4 g once daily with 800 mg three times daily for maintenance of remission in ulcerative colitis.Inflammatory bowel diseases · 2012Trial
- 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
- Thermo-responsive methylcellulose/hyaluronic acid-mesalamine hydrogel in targeted drug delivery for ulcerative colitis.RSC advances · 2025Article
- Non-Adherence Rate to Oral Mesalamine in Ulcerative Colitis Patients: A Systematic Review with Meta-Analysis.Journal of personalized medicine · 2025Review
- Safety and efficacy of multimatrix mesalamine in paediatric patients with mild-to-moderate ulcerative colitis: a phase 3, randomised, double-blind study.EClinicalMedicine · 2023Article
- The impact of clinical symptoms and endoscopic and histologic disease activity on health-related quality of life in patients with ulcerative colitis following treatment with multimatrix mesalazine.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021Article
- Patient Preference and Adherence to Aminosalicylates for the Treatment of Ulcerative Colitis.Clinical and experimental gastroenterology · 2021Review
- Colitis and Crohn's Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease.Intestinal research · 2020Review
- Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?Current treatment options in gastroenterology · 2020Review
- Adherence to Asacol once daily versus divided regimen for maintenance therapy in ulcerative colitis: a prospective, multicenter, randomized study.Intestinal research · 2019Article
- AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
- AGA Technical Review on the Management of Mild-to-Moderate Ulcerative Colitis.Gastroenterology · 2019Review
- Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial.United European gastroenterology journal · 2018Article
Corrections and comments
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Authors and funding
7 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimMaintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.
methodsThis multicentre, randomised, open-label trial enrolled patients with strictly defined clinical and endoscopic remission, immediately following an episode of mild to moderate ulcerative colitis. Patients were randomised to MMX mesalazine 2.4 g/day as a single (2x1.2 g tablet) or divided dose (1x1.2 g tablet twice daily) for 12 months.
results174 patients (37.9%; safety population n = 459) experienced 384 adverse events, the majority of which were mild or moderate in intensity. Eighteen patients (3.9%), nine in each group, experienced a total of 22 serious adverse events (10 in the once-daily and 12 in the twice-daily group). Most serious adverse events were gastrointestinal, experienced by 5 patients in the once-daily and 4 in the twice-daily group. At month 12, 64.4% (efficacy population, n = 451) of patients in the once-daily and 68.5% of patients in the twice-daily group were in clinical and endoscopic remission (p = 0.351). At month 12, 88.9% and 93.2% in each group, respectively, had maintained clinical remission (were relapse free).
conclusionsMMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated and was effective as maintenance treatment. High clinical and endoscopic remission rates can be achieved with once-daily dosing. TRIAL REGISTRATION NUMBER: NCT00151944.
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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.