Evidence map›Paper›PMID 41553253›Full record

Trial reportNeurogastroenterology and motility2026

Clinical Trial: Efficacy and Safety of Velusetrag in Chronic Intestinal Pseudo-Obstruction: A Randomized, Phase 2, Placebo-Controlled, Crossover, Multiple (n = 1), Proof-of-Concept Study.

Carolina Malagelada, Roberto De Giorgio, Rosanna Francesca Cogliandro, Luis Alcalá-González, Anna Costanzini, Valeria Scuderi, Sara Manzoni, Elena Pasquali, Jan Tack, Vincenzo Stanghellini

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Neurogastroenterology and motility, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05724069 (Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT05724069 phase2completednot on this map

Velusetrag for the Treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A Multicenter, Double-blind, Placebo-controlled, Cross-over, Multiple (n=1) Trial.

TypeinterventionalSponsorAlfasigma S.p.A.Ran2021 to 2023Enrolled17ConditionsChronic Intestinal Pseudo-obstructionArmsVelusetrag 15 mg once daily for 4 weeks., Placebo once daily for 4 weeks.
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

10 authors.

Carolina MalageladaDigestive System Research Unit, Vall d'Hebron University Hospital, Barcelona, Spain.ORCID https://orcid.org/0000-0001-7097-1492
Roberto De GiorgioDepartment of Translational Medicine, University of Ferrara, Ferrara, Italy.ORCID https://orcid.org/0000-0003-0867-5873
Rosanna Francesca CogliandroInternal Medicine and Digestive Pathophysiology, Sant'Orsola-Malpighi University Hospital, Bologna, Italy.ORCID https://orcid.org/0009-0006-1258-0569
Luis Alcalá-GonzálezDigestive System Research Unit, Vall d'Hebron University Hospital, Barcelona, Spain.ORCID https://orcid.org/0000-0003-3247-1539
Anna CostanziniDepartment of Translational Medicine, University of Ferrara, Ferrara, Italy.ORCID https://orcid.org/0000-0002-8644-1135
Valeria ScuderiR&D Department, Alfasigma S.p.A., Bologna, Italy.
Sara ManzoniR&D Department, Alfasigma S.p.A., Bologna, Italy.ORCID https://orcid.org/0009-0009-1119-5986
Elena PasqualiR&D Department, Alfasigma S.p.A., Bologna, Italy.
Jan TackDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0002-3206-6704
Vincenzo StanghelliniDepartment of Medical and Surgical Science, University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0003-0559-4875

Funding

Alfasigma S.p.A.United European Gastroenterology
6 · The paper itself

Abstract

backgroundChronic intestinal pseudo-obstruction (CIPO) is a rare, severe disorder of gastrointestinal motility. Although 5-hydroxytryptamine type 4 (5-HT

aimTo assess the efficacy and safety of velusetrag, a highly selective 5-HT

methodsThis was a phase 2, placebo-controlled, crossover, multiple (n = 1), multicenter, double-blind, proof-of-concept trial. Eligible patients were aged 18-80 years, had CIPO (idiopathic or secondary to neurodegenerative disorders) and received ≥ 30% of their daily caloric intake orally. Over four periods, each of four weeks, patients were randomly assigned to once-daily, oral velusetrag 15 mg (two periods) or placebo (two periods), with a 2-week washout between each treatment period. The primary endpoint was the improvement in the weekly global gastrointestinal symptoms average index score (WGGSAIS) from the start to the end of each treatment period, assessed among patients who were responders or naive to previous 5-HT

resultsOverall, 17 patients with idiopathic CIPO received treatment and were included in safety analyses; efficacy was assessed in 15 patients. Mean (standard deviation) changes in WGGSAIS during treatment were -0.42 (0.693) for velusetrag and -0.19 (0.688) for placebo (between-treatment difference: -0.24; 95% confidence interval: -0.553, 0.074; p = 0.1279). No deaths or serious or treatment-related treatment-emergent adverse events were reported.

conclusionVelusetrag treatment was associated with improved symptoms versus placebo, although differences were not statistically significant at this sample size. Velusetrag was generally well tolerated.

trial registrationClinicalTrials.gov identifier: NCT05724069; EudraCT number: 2021-000854-24.

Indexed as

Intestinal Pseudo-ObstructionSerotonin 5-HT4 Receptor AgonistsAdolescentAdultAgedAged, 80 and overBenzamidesChronic DiseaseCross-Over StudiesDouble-Blind MethodFemaleGastrointestinal MotilityHumansMaleMiddle AgedProof of Concept StudyBenzamidesSerotonin 5-HT4 Receptor AgonistsThiazolesZ 338functional GI diseasesmotilitysmall intestine

Identifiers

PMID41553253
PMCPMC12814924

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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.