Evidence map›Paper›PMID 25273116›Full record

ArticleJournal of neurogastroenterology and motility2014

Effect of Prucalopride in the Treatment of Chronic Constipation in Asian and Non-Asian Women: A Pooled Analysis of 4 Randomized, Placebo-controlled Studies.

MeiYun Ke, Jan Tack, Eamonn M M Quigley, Duowu Zou, Suck Chei Choi, Somchai Leelakusolvong, Andy Liu, JinYong Kim

4 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Journal of neurogastroenterology and motility, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% 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.

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
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. [Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  5. Article
  6. Safety/Efficacy of Prucalopride in Korean Patients with Chronic Constipation: Post-marketing Surveillance.The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2021
    Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
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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

8 authors at 6 institutions in 4 countries.

MeiYun KePeking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China.
Jan TackTranslational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
Eamonn M M QuigleyHouston Methodist Hospital and Weill Cornell Medical College, Houston, Texas, USA.
Duowu ZouSecond Military Medical University, Shanghai, China.
Suck Chei ChoiWonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.
Somchai LeelakusolvongSiriraj Hospital, Mahidol University, Bangkok, Thailand.
Andy LiuJanssen Research and Development, Shanghai, China.
JinYong KimJanssen Asia-Pacific, Singapore.
Janssen (Belgium) · BEKU Leuven · BEPeking Union Medical College Hospital · CNSecond Military Medical University · CNSiriraj Hospital · THWonkwang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTo compare the efficacy and safety of prucalopride, a novel selective high-affinity 5-hydroxytryptamine type 4 receptor agonist, versus placebo, in Asian and non-Asian women with chronic constipation (CC).

methodsData of patients with CC, receiving once-daily prucalopride 2-mg or placebo for 12-weeks, were pooled from 4 double-blind, randomized, phase-III trials (NCT00488137, NCT00483886, NCT00485940 and NCT01116206). The efficacy endpoints were: average of ≥ 3 spontaneous complete bowel movements (SCBMs)/week; average increases of ≥ 1 SCBMs/week; and change from baseline in each CC-associated symptom scores (bloating, abdominal pain, hard stool and straining).

resultsOverall, 1,596 women (Asian [26.6%], non-Asian [73.4%]) were included in this analysis. Significantly more patients in the prucalopride group versus placebo experienced an average of ≥ 3 SCBMs/week in Asian (34% vs. 11%, P < 0.001) and non-Asian (24.6% vs. 10.6%, P < 0.001) subgroups. The number of patients reporting an increase of≥ 1 SCBMs/week from baseline was significantly higher in the prucalopride group versus placebo among both Asian (57.4% vs. 28.3%, P < 0.001) and non-Asian (45.3% vs. 24.0%, P < 0.001) subgroups. The difference between the subgroups was not statistically significant. Prucalopride significantly reduced the symptom scores for bloating, hard stool, and straining in both subgroups.

conclusionsPrucalopride 2-mg once-daily treatment over 12-weeks was more efficacious than placebo in promoting SCBMs and improve-ment of CC-associated symptoms in Asian and non-Asian women, and was found to be safe and well-tolerated. There were numeric differences between Asian and non-Asian patients on efficacy and treatment emergent adverse events, which may be partially due to the overlap with functional gastrointestinal disorders in non-Asian patients.(J Neurogastroenterol Motil 2014;20:458-468).

Indexed as

Asian womenChronic constipationNon-Asian womenPrucaloprideSerotonin 5-HT4 receptor agonists

Identifiers

PMID25273116
PMCPMC4204404
OpenAlexW1970585703

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.