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Assessment of the effectiveness and safety of ethosuximide in the treatment of abdominal pain related to irritable bowel syndrome – IBSET: protocol of a randomised, parallel, controlled, double-blind and multicentre trial
  1. Nicolas Kerckhove1,2,3,
  2. Julien Scanzi4,
  3. Bruno Pereira2,
  4. Denis Ardid5,
  5. Michel Dapoigny4
  1. 1 Medical Pharmacology Unit, University Clermont Auvergne, CHU Clermont-Ferrand, UMR INSERM 1107 – NEURO-DOL, Clermont-Ferrand, France
  2. 2 DRCI, University Clermont Auvergne, CHU Clermont-Ferrand, UMR INSERM 1107 – NEURO-DOL, Clermont-Ferrand, France
  3. 3 Analgesia Institute, University Clermont Auvergne, Clermont-Ferrand, France
  4. 4 Gastroenterology Unit, University Clermont Auvergne, CHU Estaing, UMR INSERM 1107 – NEURO-DOL, Clermont-Ferrand, France
  5. 5 University Clermont Auvergne, UMR INSERM 1107 – NEURO-DOL, Clermont-Ferrand, France
  1. Correspondence to Dr Nicolas Kerckhove; nkerckhove{at}chu-clermontferrand.fr

Abstract

Introduction Irritable bowel syndrome (IBS) is characterised by the association of abdominal chronic pain with bowel habit disorders in the absence of identifiable organic disease. This is the first reason for consultation in gastroenterology, with an estimated prevalence of 10%–15% in industrialised countries. Although this is a benign gastrointestinal disease, its chronicity profoundly impacts the patient’s quality of life and causes considerable health spending. Actual medical treatments are poorly efficient on IBS-related abdominal pain, making it a major public health concern. The mechanisms causing IBS symptoms are unknown. Recent studies have shown the involvement of T-type channel in abdominal pain. We aim to evaluate the therapeutic potential of ethosuximide, a T-type channel blocker, on the abdominal pain of patients presenting an IBS.

Methods and analysis The IBSET trial is a randomised, controlled, parallel, double-blind and multicentre study. It is the first clinical trial evaluating the efficacy and safety of ethosuximide on abdominal pain related to IBS. Adults with IBS that report significant abdominal pain (≥4/10) at least for 3 months will be included. 290 patients will be randomly assigned to receive either ethosuximide or placebo over 12 weeks after 1 week of run-in period. The primary endpoint is the rate of responders (pain reduction ≥30% and Subject Global Assessment of Relief score ≥4). The intensity of abdominal pain will be assessed by an 11-point Numerical Rating Scale before and after 12 weeks of treatment and the score of the Subject Global Assessment of Relief scale at the end of treatment. The secondary endpoints are the safety of ethosuximide, the intensity and features of IBS and quality of life.

Ethics and dissemination The study was approved by an independent medical ethics committee (CPP Sud-Est VI, Clermont-Ferrand, France). The results will be published in a peer-review journal and presented at international congresses.

Trial registration number NCT02973542; Pre-results.

  • ibs
  • t-type calcium channel
  • ethosuximide

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Footnotes

  • Contributors NK, JS, DA and MD led and contributed to the conceptualisation, design and implementation of this research protocol. BP led the development of the statistical analysis plan. NK participated in the design of the protocol for interventions and assessments. All the authors have read and approved the final manuscript.

  • Funding This work is supported by funding from the French Ministry for Health (‘Programme Hospitalier de Recherche Clinique Interrégional’, year 2015) and the SFETD (‘Société Française d'Etude et de Traitement de la Douleur’).

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The approval of the medical ethics committee (CPP Sud Est VI, Clermont-Ferrand, France) was obtained on 10/10/2016 (ref: AU 1274).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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