Evidence map›Paper›PMID 41214272›Full record

Trial reportJournal of gastroenterology and hepatology2025

The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint.

Darren M Brenner, Andrea S Shin, Adam P Laitman, Jill K Deutsch, David C Kunkel

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gastroenterology and hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02387359 phase3completednot on this map

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2014 to 2017Enrolled1,054ConditionsIrritable Bowel Syndrome Characterized by ConstipationArmsPlecanatide, Placebo
NCT02493452 phase3completednot on this map

Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2015 to 2017Enrolled1,135ConditionsIrritable Bowel Syndrome Characterized by ConstipationArmsPlecanatide, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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

5 authors.

Darren M BrennerInternal Medicine-Gastroenterology, Northwestern University-Feinberg School of Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0002-8577-7278
Andrea S ShinVatche and Tamar Manoukian Division of Digestive Diseases, Department of Medicine, University of California, Los Angeles, Los Angeles, California, USA.
Adam P LaitmanSalix Pharmaceuticals, Bridgewater, New Jersey, USA.
Jill K DeutschSection of Digestive Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
David C KunkelDivision of Gastroenterology, University of California San Diego, La Jolla, California, USA.

Funding

Salix Pharmaceuticals
6 · The paper itself

Abstract

BACKGROUND AND

aimIrritable bowel syndrome with constipation (IBS-C) is characterized by multiple sensory symptoms, including abdominal pain, bloating, and bowel habit alterations. Therapeutic response should address all components. This study assesses a new exploratory trisymptom composite efficacy endpoint in an IBS-C population of young adults with bloating treated with plecanatide.

methodsPooled data were analyzed from two phase 3, randomized, double-blind trials. Patients (18-40 years) with IBS-C and baseline bloating (score ≥ 1) received plecanatide 3 mg or placebo for 12 weeks. The composite response definition was simultaneous improvement from baseline in three symptoms (abdominal pain, bloating, and complete spontaneous bowel movements [CSBMs]/week) for ≥ 6 of 12 weeks using several thresholds (≥ 2-point or ≥ 30% or ≥ 40% improvement in abdominal pain and bloating plus an increase of ≥ 1 or ≥ 2 CSBMs in the same week).

resultsSix hundred and five adults were included (plecanatide [n = 313]; placebo [n = 292]). Plecanatide/placebo baseline mean symptom scores were 6.2/6.4 for abdominal pain and 6.4/6.6 for bloating; both had a mean of 0.2 CSBMs/week. Significantly more patients in plecanatide versus placebo groups (p ≤ 0.01 for all comparisons) were trisymptom composite responders by several stringent thresholds, including ≥ 30% improvement in pain and bloating plus ≥ 1 CSBM/week increase (23.3% vs. 13.4%; p = 0.002) and ≥ 30% improvement in pain and bloating plus ≥ 2 CSBMs/week increase (19.5% vs. 8.9%; p < 0.001). Plecanatide was well tolerated.

conclusionPlecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating.

trial registrationClinicalTrials.gov identifiers-NCT02387359 and NCT02493452.

Indexed as

ConstipationFlatulenceIrritable Bowel SyndromeNatriuretic PeptidesAbdominal PainAdolescentAdultDefecationDouble-Blind MethodFemaleHumansMaleTreatment OutcomeYoung AdultNatriuretic Peptidesplecanatideabdominal painbloatingconstipationguanylate cyclase C agonistsirritable bowel syndrome

Identifiers

PMID41214272
PMCPMC12666612

What OpenQuestion holds

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LicenceCC BY
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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.