Evidence map›Paper›PMID 24732867›Full record

Trial reportThe American journal of gastroenterology2014

Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis.

Anton Emmanuel, Marina Cools, Lieve Vandeplassche, René Kerstens

3 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The American journal of gastroenterology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 34 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 6 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT00596596 phase2completednot on this map

A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation

TypeinterventionalSponsorMovetisRan1996 to 1997Enrolled313ConditionsConstipationArmsprucalopride, 2 mg prucalopride, 4 mg prucalopride, Placebo
NCT00617513 phase2completednot on this map

A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

TypeinterventionalSponsorMovetisRan1995 to 1996Enrolled174ConditionsConstipationArmsPrucalopride, Placebo
NCT00631813 phase2completednot on this map

A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

TypeinterventionalSponsorMovetisRan1995 to 1997Enrolled253ConditionsConstipationArmsPrucalopride, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 6 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  17. Observational
  18. Article
  19. Bowel Dysfunction in Spinal Cord Injury.Current gastroenterology reports · 2018
    Review
  20. Prucalopride Inhibits Proliferation of Ovarian Cancer Cells via Phosphatidylinositol 3-Kinase (PI3K) Signaling Pathway.Medical science monitor : international medical journal of experimental and clinical research · 2018
    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

4 authors at 2 institutions in 2 countries.

Anton EmmanuelGI Physiology Unit, University College London, London, UK.
Marina CoolsShire-Movetis NV, Turnhout, Belgium.
Lieve VandeplasscheShire-Movetis NV, Turnhout, Belgium.
René KerstensShire-Movetis NV, Turnhout, Belgium.
AZ Turnhout · BEUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesConstipation is often characterized by slow colonic transit, but the relationship between colonic transit time (CTT) and symptoms is unclear. The aims of this study were to investigate the effect of prucalopride, a 5-hydroxytryptamine receptor-4 agonist, on CTT and assess the relationship between CTT and symptoms.

methodsThis was an integrated analysis of three randomized, placebo-controlled, phase 2 dose-finding trials of prucalopride in patients with chronic constipation (ClinicalTrials.gov identifiers: NCT00617513; NCT00631813; and NCT00596596). Measurements of CTT were analyzed using radio-opaque markers at the start and end (4 or 12 weeks) of treatment. At these visits, patients assessed the presence and severity of their symptoms.

resultsIn total, 280 patients had CTT measurements before and at the end of treatment and were included in the analysis. Their mean age was 43 years, 93% were women, and mean duration of constipation was 19 years. After a once daily treatment with prucalopride 2 mg (n=98) and 4 mg (n=70), CTT was reduced by 12.0 h (95% confidence interval (CI): -18.9, -5.1) and 13.9 h (95% CI: -20.5, -7.4), respectively; CTT increased by 0.5 h (95% CI: -4.5, 5.5) with placebo (n=112). At the end of the trial, symptoms including bloating/flatulence/distension and straining were rated as severe or very severe by a higher proportion of patients with slow or very slow CTT (>48 h) than by those with normal CTT.

conclusionsThere was a clear relationship between increased CTT and increased symptom severity in patients with chronic constipation. Treatment with prucalopride accelerated CTT in these individuals.

Indexed as

AdolescentAdultAgedBenzofuransChronic DiseaseColonConstipationFemaleGastrointestinal TransitHumansMaleMiddle AgedSerotonin 5-HT4 Receptor AgonistsSeverity of Illness IndexTreatment OutcomeYoung AdultBenzofuransprucaloprideSerotonin 5-HT4 Receptor Agonists

Identifiers

PMID24732867
PMCPMC4050523
OpenAlexW2108950000

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.