ArticleClinical pharmacology in drug development2015
Absence of QTc Prolongation with Domperidone: A Randomized, Double-Blind, Placebo- and Positive-Controlled Thorough QT/QTc Study in Healthy Volunteers.
Article in Clinical pharmacology in drug development, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03021616 (Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers), which is not on this map. Cited by 14 papers.
What it found
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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.
Evaluation of Energy Drink Consumption on Electrocardiographic, Vascular and Hematologic Parameters in Young Healthy Volunteers: A Randomized, Double Blind, Active-Controlled, Crossover Study
Who cites it
14 citing papers in PubMed, 30 citations in OpenAlex.
- Results of a Phase 1 Study Assessing the Effect of CIN-102, a Novel Formulation of the Dopamine Receptor Antagonist Domperidone Designed to Treat Gastroparesis, on Cardiac Repolarization in Healthy Volunteers.Clinical pharmacology in drug development · 2026Trial
- SUpporting Mothers Milk Intervention Trial (SUMMIT) - a randomised controlled trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants - study protocol.International breastfeeding journal · 2026Article
- Potentially Hazardous Drug-Drug Interactions Associated With Oral Antineoplastic Agents Prescribed in Chinese Tertiary Care Teaching Hospital Settings: A Multicenter Cross-Sectional Study.Frontiers in pharmacology · 2022Article
- Treatment paradigms in Parkinson's Disease and Covid-19.International review of neurobiology · 2022Article
- Non-Clinical Safety Pharmacology Evaluations of Trazpiroben (TAK-906), a Novel Dopamine DJournal of experimental pharmacology · 2022Article
- Nausea and Vomiting in 2021: A Comprehensive Update.Journal of clinical gastroenterology · 2021Review
- Effect of domperidone, ondansetron, olanzapine-containing antiemetic regimen on QTScientific reports · 2021Observational
- The use of a clinical decision support tool to assess the risk of QT drug-drug interactions in community pharmacies.Therapeutic advances in drug safety · 2021Article
- Risk of domperidone induced severe ventricular arrhythmia.Scientific reports · 2020Article
- Antiemetic drugs: what to prescribe and when.Australian prescriber · 2020Review
- Cardiovascular alterations in rats with Parkinsonism induced by 6-OHDA and treated with Domperidone.Scientific reports · 2019Article
- What Evidence Do We Have for Pharmaceutical Galactagogues in the Treatment of Lactation Insufficiency?-A Narrative Review.Nutrients · 2019Review
- A meta-analysis on the cardiac safety profile of domperidone compared to metoclopramide.United European gastroenterology journal · 2018Article
- Prokinetics in the Management of Functional Gastrointestinal Disorders.Current gastroenterology reports · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Domperidone effects on QTc duration were assessed in a single-center, double-blind, four-way crossover study of 44 healthy participants randomized to one of four treatment sequences consisting of four treatment periods separated by 4-9 days washout. On Day 1 of each 4-day period, participants began oral domperidone 10 or 20 mg q.i.d., matching placebo q.i.d., or single-dose moxifloxacin 400 mg (positive control)/placebo q.i.d. In each period, triplicate 12-lead electrocardiograms were recorded at baseline (30, 20, and 10 minutes predose), 8 timepoints after dosing on Days 1 and 4, and predose on Day 4. In mixed effects models, the largest difference for domperidone in least squares means for change from baseline QTcP versus placebo was 3.4 milliseconds (20 mg q.i.d., Day 4), 90% CI: 1.0-5.9, and <10 milliseconds at all timepoints for both domperidone dosages. Moxifloxacin response confirmed assay sensitivity. Participants achieved expected domperidone plasma exposures. No significant exposure-response relationship was found for QTc increase per ng/mL domperidone (90% CI of the slope estimate included zero at mean C
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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.