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Prucalopride in Gastroparesis: A Randomized Placebo-Controlled Crossover Study
Abstract
Objectives Prokinetics are considered the preferred treatment option for gastroparesis, but evidence of their efficacy is scarce. Prucalopride, a selective 5-hydroxytryptamine 4 receptor agonist used in the treatment of constipation, is able to enhance the gastric emptying rate. In a double-blind, randomized, placebo-controlled crossover study, we evaluated the efficacy of prucalopride to improve the gastric emptying rate and symptoms in patients with gastroparesis. Methods Thirty-four patients with gastroparesis (28 idiopathic, 7 men, mean age 42 ± 13 years) were evaluated in a double-blind crossover trial of 4-week treatment periods with placebo or prucalopride 2 mg q.d., separated by 2 weeks of washout. The primary end point was the change in symptom severity, assessed by the Gastroparesis Cardinal Symptom Index; secondary end points comprised the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life, and daily diaries, and the gastric emptying rate was assessed by the C-octanoic acid breath test. Results Three patients were lost to follow-up. One serious adverse event occurred (small bowel volvulus in the prucalopride group), and 3 patients dropped out because of adverse events of nausea and headache (all prucalopride). For the entire patient group, compared with placebo, prucalopride significantly improved the total Gastroparesis Cardinal Symptom Index (1.65 ± 0.19 vs 2.28…
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“The selective 5‑HT4 receptor agonist prucalopride may improve nausea, early satiety, bloating, and quality of life in selected patients, though it carries gastrointestinal side effects and requires individualization [49, 124, 125].”
From Diabetic gastroparesis: pathophysiology and impact on insulin timing choices (2026) · cites this paper as [125]
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Metadata
- Authors
- Carbone, F., Van den Houte, K., Clevers, E., Andrews, C. N., Papathanasopoulos, A., Holvoet, L., Van Oudenhove, L., Caenepeel, P., Arts, J., Vanuytsel, T., & Tack, J.
- Affiliations
- KU Leuven (BE)
- Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.
- Corresponding author
- Tack, Jan
- Venue
- American Journal of Gastroenterology
- Published
- 2019-07-08
- Volume
- 114
- Issue
- 8
- Pages
- 1265-1274
- ISSN
- 0002-9270 (ISSN-L)
- 1572-0241
- OpenAlex
- W2958890085
- Cited by
- 206
- References
- 32
- Citations by year
- 2026: 19 · 2025: 21 · 2024: 25 · 2023: 30 · 2022: 27 · 2021: 39 · 2020: 33 · 2019: 9
- FWCI
- 24.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Lirias (submittedVersion)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Surgery › Nausea and vomiting management
- Health Sciences › Medicine › Gastroenterology › Gastroesophageal reflux and treatments
- Keywords
- prucalopride, gastroparesis, prokinetic agents, 5-HT4 receptor agonist, gastric emptying, Gastroparesis Cardinal Symptom Index, quality of life, idiopathic gastroparesis, nausea and vomiting, small bowel volvulus, adverse events, gastric emptying half-time, crossover trial
- MeSH terms
- Adult, Benzofurans, Breath Tests, Double-Blind Method, Female, Gastric Emptying, Humans, Male, Quality of Life, Severity of Illness Index, Gastroparesis, Cross-Over Studies, Serotonin 5-HT4 Receptor Agonists
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