Trial reportThe American journal of gastroenterology2015
A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation.
Trial report in The American journal of gastroenterology, 2015. 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 43 papers, 4 of them syntheses that pooled 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.
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.
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
An Evaluation of the Efficacy and Safety of a Polyethylene Glycol (PEG) Based Bowel Protocol for the Management of Constipation in Peritoneal Dialysis Patients: A Pilot Study
Characteristics of INTESTINAL DYSFUNCTION in Patients With MULTIPLE SCLEROSIS. Effectiveness of the TRANSANAL IRRIGATION PROCEDURE With the PERISTEEN DEVICE in the Treatment of Constipation and Disease-related Anal Incontinence
Who cites it
43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- [Seoul Consensus on Clinical Practice Guidelines for Functional Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025Guideline
- American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation.Gastroenterology · 2023Guideline
- Different doses of prucalopride in treating chronic idiopathic constipation: a meta-analysis and Bayesian analysis.BMJ open · 2021Pooled it
- Use of Prucalopride for Chronic Constipation: A Systematic Review and Meta-analysis of Published Randomized, Controlled Trials.Journal of neurogastroenterology and motility · 2016Pooled it
- Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Multicenter, Randomized Controlled Study.United European gastroenterology journal · 2025Trial
- Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints.Canadian journal of gastroenterology & hepatology · 2022Trial
- Trial
- Preliminary safety and efficacy profile of prucalopride in the treatment of systemic sclerosis (SSc)-related intestinal involvement: results from the open label cross-over PROGASS study.Arthritis research & therapy · 2017Trial
- Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial.Integrative medicine research · 2026Article
- Deep phenotyping of patient lived experience in functional bowel disorders using machine learning.Scientific reports · 2025Article
- Pharmacokinetics and bioequivalence assessment of two prucalopride formulations in healthy Chinese women: a randomized, open-label, two-period, two-sequence, self-crossover study.Frontiers in pharmacology · 2025Article
- Comparison of enteral prucaloprideFrontiers in pharmacology · 2024Article
- 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.Therapeutic advances in gastroenterology · 2024Article
- 5-HT4 receptor agonists treatment reduces tau pathology and behavioral deficit in the PS19 mouse model of tauopathy.Frontiers in cellular neuroscience · 2024Article
- 2022 Seoul Consensus on Clinical Practice Guidelines for Functional Constipation.Journal of neurogastroenterology and motility · 2023Review
- Effects of acupuncture on gut microbiota and short-chain fatty acids in patients with functional constipation: a randomized placebo-controlled trial.Frontiers in pharmacology · 2023Article
- Tissue distribution and abuse potential of prucalopride: findings from non-clinical and clinical studies.Drugs in context · 2023Article
- Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol.Contemporary clinical trials communications · 2022Article
- Safety/Efficacy of Prucalopride in Korean Patients with Chronic Constipation: Post-marketing Surveillance.The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2021Article
- Bisacodyl: A review of pharmacology and clinical evidence to guide use in clinical practice in patients with constipation.Neurogastroenterology and motility · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 10 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesPrucalopride is effective at alleviating symptoms of chronic constipation in women. The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation.
methodsThis was a multicenter, stratified, randomized, parallel-group, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov identifier: NCT01147926). The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week across the treatment period. Efficacy end points were assessed using daily electronic diaries, global assessment of the severity of constipation and efficacy of treatment, and Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires.
resultsIn total, 374 patients were enrolled in the study. Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group (37.9%) than in the placebo group (17.7%, P<0.0001). The proportion of patients rating their constipation treatment as "quite a bit" to "extremely" effective at the final on-treatment visit was 46.7 and 30.4% in the prucalopride and placebo groups, respectively. The difference between treatment groups was statistically significant (P<0.0001). The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8% in the prucalopride and placebo groups, respectively (P=0.0035). Prucalopride had a good safety profile and was well tolerated.
conclusionsPrucalopride is effective, has a good safety profile, and is well tolerated for the treatment of men with chronic constipation.
Indexed as
Identifiers
What OpenQuestion holds
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.