Evidence map›Paper›PMID 31151306›Full record

Trial reportCells2019

A Phase 2a, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial of IBD98-M Delayed-Release Capsules to Induce Remission in Patients with Active and Mild to Moderate Ulcerative Colitis.

Gionata Fiorino, Giacomo Carlo Sturniolo, Fabrizio Bossa, Andrea Cassinotti, Antonio di Sabatino, Paolo Giuffrida, Silvio Danese

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cells, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Oral 5-aminosalicylic acid for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022
    Review
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Gionata FiorinoDivision of Gastroenterology, IBD Center, Humanitas Clinical and Research Center, 20089 Milan, Italy. gionataf@gmail.com.ORCID 0000-0001-5623-2968
Giacomo Carlo SturnioloAzienda Ospedaliera di Padova, 35128 Padova, Italy. gc.sturniolo@unipd.it.
Fabrizio BossaFondazione Casa Sollievo della Sofferenza IRCCS-Gastroenterology Department, 71013 Foggia, Italy. f.bossa@icloud.com.ORCID 0000-0002-4518-9949
Andrea CassinottiUOC Gastroenterologia, ASST Fatebenefratelli Sacco, Luigi Sacco University Hospital, 20157 Milano, Italy. andreacassinotti@libero.it.
Antonio di SabatinoDipartimento Area Medica S.C. Medicina Generali, IRCCS Policlinico San Matteo, 27100 Pavia, Italy. A.DiSabatino@smatteo.pv.it.
Paolo GiuffridaDipartimento Area Medica S.C. Medicina Generali, IRCCS Policlinico San Matteo, 27100 Pavia, Italy. p.giuffrida@ucl.ac.uk.
Silvio DaneseDivision of Gastroenterology, IBD Center, Humanitas Clinical and Research Center, 20089 Milan, Italy. sdanese@hotmail.com.
Humanitas University · ITPoliclinico San Matteo Fondazione · ITASST Fatebenefratelli Sacco · ITAzienda Ospedale - Università Padova · ITCasa Sollievo della Sofferenza · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IBD98-M is a delayed-release formulation of mesalamine (mesalazine) and SH with a potential therapeutic role in ulcerative colitis (UC). A total of 51 patients with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of ≥4 and ≤10, and a modified UCDAI endoscopy subscore ≥1 were randomized for 6 weeks of double-blind treatment with IBD98 0.8 g/day or IBD 1.2 g/day or placebo. The efficacy and safety of IBD98-M in mild to moderate active UC were primarily evaluated. At week 6, 1 (5.9%), 2 (12.5%), and 2 (11.1%) patients receiving IBD98-M 0.8 g, IBD98-M 1.2 g, and placebo, respectively, (

Indexed as

AdultCapsulesColitis, UlcerativeDelayed-Action PreparationsDouble-Blind MethodEndoscopyFemaleHumansMaleMesalamineMiddle AgedPlacebosRemission InductionSulfasalazineTreatment OutcomeCapsulesDelayed-Action PreparationsMesalaminePlacebosSulfasalazine5-ASAIBD98-Minflammatory bowel diseasemesalaminemesalazinesodium hyaluronateulcerative colitis

Identifiers

PMID31151306
PMCPMC6627752
OpenAlexW2947367043

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.