Evidence map›Paper›PMID 39664231›Full record

ArticleTherapeutic advances in gastroenterology2024

Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies.

Anthony Lembo, Kyle Staller, Mena Boules, Paul Feuerstadt, William Spalding, André Gabriel, Ashraf Youssef, Yunlong Xie, Brian Terreri, Brooks D Cash

6 registry-linked trialsAbstract read
In one paragraph

Article in Therapeutic advances in gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are 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.

NCT00483886 phase3completednot on this map

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation.

TypeinterventionalSponsorMovetisRan1998 to 1999Enrolled620ConditionsConstipationArmsPrucalopride, Placebo
NCT00485940 phase3completednot on this map

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation

TypeinterventionalSponsorMovetisRan1998 to 1999Enrolled641ConditionsConstipationArmsPrucalopride, Placebo
NCT00488137 phase3completednot on this map

A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride (R108512) Tablets in Subjects With Chronic Constipation

TypeinterventionalSponsorMovetisRan1998 to 1999Enrolled716ConditionsConstipationArmsPrucalopride, Placebo
NCT01116206 phase3completednot on this map

A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation

TypeinterventionalSponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ran2010 to 2011Enrolled507ConditionsConstipationArmsPrucalopride, Placebo
NCT01147926 phase3completednot on this map

A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation

TypeinterventionalSponsorShireRan2010 to 2013Enrolled374ConditionsMale Subjects With Chronic ConstipationArmsPlacebo, Prucalopride
NCT01424228 phase4completednot on this map

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Long-term Treatment (24 Weeks) With Prucalopride in Subjects Aged ≥18 Years With Chronic Constipation

TypeinterventionalSponsorShireRan2011 to 2012Enrolled364ConditionsConstipationArmsplacebo, prucalopride
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

10 authors.

Anthony LemboDigestive Disease Institute, Cleveland Clinic, Main Campus, 9500 Euclid Avenue, Cleveland, OH 44195, USA.ORCID https://orcid.org/0000-0002-4479-1188
Kyle StallerDivision of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA.ORCID https://orcid.org/0000-0003-4925-4290
Mena BoulesTakeda Pharmaceuticals USA, Inc., Lexington, MA, USA.
Paul FeuerstadtPACT Gastroenterology Center, Hamden, CT, USA Yale University School of Medicine, New Haven, CT, USA.ORCID https://orcid.org/0000-0002-7643-9576
William SpaldingTakeda Development Center Americas, Inc., Lexington, MA, USA.
André GabrielTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Ashraf YoussefTakeda Pharmaceuticals USA, Inc., Cambridge, MA, USA.
Yunlong XieTakeda Development Center Americas, Inc., Cambridge, MA, USA.
Brian TerreriTakeda Pharmaceuticals USA, Inc., Lexington, MA, USA.
Brooks D CashDivision of Gastroenterology, Hepatology, and Nutrition, University of Texas Health Science Center at Houston, Houston, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Prucalopride (1 or 2 mg once daily) is approved for treating adults with chronic idiopathic constipation (CIC). Objectives: We determined the effect of age, body mass index (BMI), and renal function on the efficacy and safety of prucalopride in adults with CIC. Design: Data were pooled from six 12-week, phase III-IV clinical studies in adults who received prucalopride (1 or 2 mg once daily) or placebo for CIC. Methods: Adults were stratified by age (<50; 50-64; ⩾65 years), BMI (underweight/healthy weight, <25 kg/m Results: Of 2484 patients stratified by age (prucalopride, Conclusion: Prucalopride demonstrated efficacy in adults with CIC, irrespective of age, BMI, and renal function. No unexpected safety concerns were identified. Trial registration: ClinicalTrials.gov identifiers (https://clinicaltrials.gov/): NCT01147926, NCT01424228, NCT01116206, NCT00483886, NCT00485940, NCT00488137.

Indexed as

agebody mass indexchronic idiopathic constipationpooled analysisprucalopriderenal function

Identifiers

PMID39664231
PMCPMC11632959

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.