Trial reportAlimentary pharmacology & therapeutics2012
Randomised clinical trial: the efficacy of prucalopride in patients with chronic intestinal pseudo-obstruction--a double-blind, placebo-controlled, cross-over, multiple n = 1 study.
Trial report in Alimentary pharmacology & therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Guideline
- [Irritable bowel syndrome with constipation and functional constipation in adults: Treatment (Part 2 of 2)].Atencion primaria · 2017Guideline
- Prucalopride: For functional constipation only?Techniques in coloproctology · 2016Pooled it
- Clinical Trial: Efficacy and Safety of Velusetrag in Chronic Intestinal Pseudo-Obstruction: A Randomized, Phase 2, Placebo-Controlled, Crossover, Multiple (n = 1), Proof-of-Concept Study.Neurogastroenterology and motility · 2026Trial
- Review of nutrition management of pediatric intestinal pseudo-obstruction.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026Review
- Gastrointestinal involvement in systemic sclerosis: A spotlight on small bowel involvement, complications and management.Best practice & research. Clinical rheumatology · 2026Review
- Systemic Sclerosis-Related Intestinal Pseudo-Obstruction Mimicking Mechanical Small Bowel Obstruction.Cureus · 2026Article
- Gastrointestinal Dystonia in Children and Young People with Severe Neurological Impairment & Palliative Care Needs: A Systematic Review.Children (Basel, Switzerland) · 2025Review
- Pediatric Chronic Intestinal Failure: Something Moving?Nutrients · 2024Review
- Neurogastroenterology and Motility Disorders of the Gastrointestinal Tract in Cystic Fibrosis.Current gastroenterology reports · 2024Review
- Prucalopride for Treatment of Upper Gastrointestinal Symptoms in Children.Paediatric drugs · 2022Article
- Recent Advances in the Management of Severe Gastrointestinal Dysmotility.Clinical and experimental gastroenterology · 2021Review
- Latest developments in chronic intestinal pseudo-obstruction.World journal of clinical cases · 2020Review
- Gastroesophageal Reflux Disease and Foregut Dysmotility in Children with Intestinal Failure.Nutrients · 2020Review
- Small Bowel Dysmotility, Pseudoobstruction, and Functional Correlation with Histopathology: Lessons Learned.Current gastroenterology reports · 2020Review
- Chronic intestinal pseudo-obstruction due to al amyloidosis: a case report and literature review.Clinical journal of gastroenterology · 2019Review
- Recent advances in understanding and managing chronic constipation.F1000Research · 2018Review
- An update on prucalopride in the treatment of chronic constipation.Therapeutic advances in gastroenterology · 2017Review
- [Motility disorders of the small intestine].Der Internist · 2015Review
- Metabolic kinetics of 5-hydroxytryptamine and the research targets of functional gastrointestinal disorders.Digestive diseases and sciences · 2014Review
Corrections and comments
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Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic intestinal pseudo-obstruction is a disabling condition for which there are no established drug therapies. The condition is caused by a diverse range of intestinal myopathies and neuropathies.
aimTo assess the therapeutic efficacy of prucalopride, a selective high-affinity 5-HT(4) receptor agonist, we employed a multiple n = 1 study design. Each patient acted as his/her own control, each day counting as one treatment episode, allowing comparison of 168 days on each of active drug and placebo.
methodsDouble-blind, randomised, placebo-controlled, cross-over trial of four 12-week treatment periods, with 2-4 mg prucalopride or placebo daily. In each of the first and second 6 months there was a prucalopride and a placebo treatment. Patients with proven chronic intestinal pseudo-obstruction, including dilated gut, were included. Evaluation was by patient diary and global evaluation.
resultsSeven patients participated (mean 42 years, five female, median symptom duration 11 years). Three discontinued, two due to study length, and one on prucalopride due to unrelated malnutrition and bronchopneumonia. Four patients (three visceral myopathy and one visceral neuropathy) completed the study; prucalopride significantly improved pain in three of four patients, nausea in two, vomiting in one, bloating in four and analgesic intake. Bowel function was not changed substantially.
conclusionsn = 1 studies in rare conditions allow drug efficacy assessment. Prucalopride relieves symptoms in selected patients with chronic pseudo-obstruction.
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