Trial reportBritish journal of clinical pharmacology2012
Pharmacokinetic interaction between domperidone and ketoconazole leads to QT prolongation in healthy volunteers: a randomized, placebo-controlled, double-blind, crossover study.
Trial report in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- Updates on the role of adrenal steroidogenesis inhibitors in Cushing's syndrome: a focus on novel therapies.Pituitary · 2016Pooled it
- Domperidone and Risk of Ventricular Arrhythmia and Cardiac Death: A Systematic Review and Meta-analysis.Clinical drug investigation · 2016Pooled it
- 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
- A thorough QTc study to evaluate the effects of oral rilzabrutinib administered alone and with ritonavir in healthy subjects.Clinical and translational science · 2022Trial
- Evaluation of the Pharmacokinetics of Trazpiroben (TAK-906), a Peripherally Selective DClinical pharmacology : advances and applications · 2021Trial
- Lomitapide at supratherapeutic plasma levels does not prolong the Qtc interval--results from a TQT study with moxifloxacin and ketoconazole.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2013Trial
- 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
- Use and misuse of domperidone in patients living with Parkinson disease in France.Fundamental & clinical pharmacology · 2025Article
- Pilot Study on QTc Interval in Dogs Treated with Domperidone.Veterinary sciences · 2024Article
- A Physiologically Based Pharmacokinetic Model of Ketoconazole and Its Metabolites as Drug-Drug Interaction Perpetrators.Pharmaceutics · 2023Article
- Metabolic and electrolyte abnormalities as risk factors in drug-induced long QT syndrome.Biophysical reviews · 2022Review
- 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
- 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
- Metabolomics Analysis of Laparoscopic Surgery Combined with Wuda Granule to Promote Rapid Recovery of Patients with Colorectal Cancer Using UPLC/Q-TOF-MS/MS.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data.International journal of environmental research and public health · 2019Article
- A meta-analysis on the cardiac safety profile of domperidone compared to metoclopramide.United European gastroenterology journal · 2018Article
- Use of domperidone in canine visceral leishmaniasis: gaps in veterinary knowledge and epidemiological implications.Memorias do Instituto Oswaldo Cruz · 2018Article
- Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.SLAS discovery : advancing life sciences R & D · 2018Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
aimsTo assess the steady-state pharmacokinetic and QT(c) effects of domperidone and ketoconazole, given alone and together.
methodsA randomized, placebo-controlled, double-blind, crossover study was carried out. Healthy subjects (14 men, 10 women; age 18-39 years; mean weight 73.5kg, range 53.8-98.8kg; 23 Europid, 1 Afro-Caribbean) received orally, for 7 days each, placebo, domperidone 10mg, four doses daily, at 4h intervals, ketoconazole 200mg 12-hourly and domperidone and ketoconazole together. The washout period was 15 days. Pharmacokinetics and serial 12-lead ECGs were assessed on day 7, and serial ECGs on day -1 and at follow-up. Two subjects withdrew before the third treatment period, so data were available for 22-24 subjects. RESULTS Ketoconazole tripled domperidone concentrations at steady-state. Domperidone, ketoconazole and their combination significantly increased QT(c) F in men. Overall adjusted mean differences from placebo were 4.20 (95% CI 0.77, 7.63), 9.24 (95% CI 5.85, 12.63) and 15.90 (95% CI 12.47, 19.33) ms, respectively. In women, QT(c) F was not significantly different from placebo on either domperidone or ketoconazole alone, or in combination. However, QT(c) was positively correlated with plasma drug concentrations, in both men and women. ΔQT(c) F increased by about 2ms per 10ngml(-1) rise in domperidone concentration, and per 1µgml(-1) rise in ketoconazole concentration.
conclusionsKetoconazole tripled the plasma concentrations of domperidone. Domperidone and ketoconazole increased QT(c) F in men, whether given together or separately. The effect of domperidone alone was below the level of clinical importance. The negative result in women is unexplained.
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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.