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Ethosuximide to Treat IBS (IBSET)

Primary Purpose

Irritable Bowel Syndrome

Status
Active
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ethosuximide
Placebo
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Ethosuximide, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years,

    • Man,
    • Women, Negative pregnancy test and effective contraception,
    • IBS defined by the Rome criteria IV
    • During the previous seven days the inclusion visit, average NRS pain ≥ 4,
    • IBS Treatment stable for 1 month
    • Patients affiliated to the French Social Security,
    • Patients with the informed consent were obtained.

Exclusion Criteria:

  • Breastfeeding
  • Diabetic patients
  • Known renal or hepatic impairment,
  • Significant liver function abnormalities (transaminases> 3N, cholestasis) and renal (MDRD <60 ml / min)
  • Addiction to alcohol and / or drugs,
  • AEDs taken (epilepsy or chronic pain)
  • chronic pain of greater intensity than that related to IBS,
  • Allergy succinimides (ethosuximide, methsuximide, phensuximide)
  • History or current severe depression (hospitalization, long-term antidepressant treatment)
  • Psychotic disorders,
  • Patients exclusion period, or total exceeded authorized allowances
  • Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

Sites / Locations

  • CHU Clermont-Ferrand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ethosuximide

placebo

Arm Description

A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).

A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).

Outcomes

Primary Outcome Measures

30% reduction in abdominal pain
Score of 4 or 5 on the SGA scale

Secondary Outcome Measures

Monthly assessment of abdominal pain
Monthly assessment of score of Bristol scale
Monthly evaluation of GIQLI questionnaire
Monthly evaluation of EQ-5D questionnaire
Monthly evaluation of IBS-SSS questionnaire
Monthly evaluation of SGA scale.
Monthly evaluation of the use of analgesics
Monthly evaluation of the use of antispasmodic
Monthly evaluation of the use of regulators transit.
Monthly evaluation of medical response rate
Monthly evaluation of stop work related to IBS.
Evaluation of the tolerance of ethosuximide throughout the study.
Evaluation of the discontinuation rate study because of adverse events throughout the study

Full Information

First Posted
November 18, 2016
Last Updated
January 5, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SFETD (Socièté Française d'Etude et de Traitement de la Douleur)
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1. Study Identification

Unique Protocol Identification Number
NCT02973542
Brief Title
Ethosuximide to Treat IBS
Acronym
IBSET
Official Title
Evaluation of the Efficacy and Tolerance of Ethosuximide in the Treatment of Abdominal Pain Associated With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SFETD (Socièté Française d'Etude et de Traitement de la Douleur)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Abdominal pain remains the most deleterious symptom for patients with irritable bowel syndrome (IBS) and is causing a significant alteration of their quality of life. The visceral hypersensitivity seems to be one of the key mechanisms that could explain the abdominal pain in these patients. Current treatments, mainly symptomatic, are of limited effectiveness, especially in terms of relief of abdominal pain. The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
Detailed Description
The irritable bowel syndrome (IBS) is characterized by a combination of discomfort and / or abdominal pain and bowel habits in the absence of identifiable organic pathology. This condition is extremely common because it is the first cause of consultation in gastroenterology and would cover 10-15% of the French. This chronic condition, although functional, impact significantly on the quality of life of patients and causes considerable health spending, making it a major public health problem. Especially as the currently used treatments are of limited effectiveness. Among the pathophysiological mechanisms involved in IBS, visceral hypersensitivity (VHS) seems to be a major factor causing pain in patients. VHS involves sensitization of colonic nerve fibers, resulting in an increase of neuronal excitability. In several animal models of chronic pain, this hyperexcitability was related to a change in the expression or activity of ion channels, including calcium channel Cav3.2. Investigators especially shown the involvement of Cav3.2 channels in visceral pain in an animal model of VHS. Furthermore, overexpression of these channels at the peripheral level (dorsal root ganglion innervating the colon) has been demonstrated in this animal model and pharmacological blockade, including ethosuximide, prevented the development of the VHS. Note that Cav3.2 channels have been widely demonstrated as involved in nociceptive phenomena in various animal models of chronic pain and that by blocking their ethosuximide induce an analgesic effect in these models. Finally, we have recently demonstrated the involvement of Cav3.2 channel in patients with IBS, in a clinical case-control study. The Cav3.2 channels were overexpressed in the colonic mucosa of patients with IBS compared to asymptomatic controls. The Cav3.2 channels are therefore a potential pharmacological target and ethosuximide a promising therapy to effectively treat the abdominal pain associated with IBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS, Ethosuximide, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ethosuximide
Arm Type
Experimental
Arm Description
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A responder will correspond to a decrease in abdominal pain score (11-points NRS pain) of at least 30% compared to the score before treatment and a score of 6 or 7 on the SGA scale. At endpoint (12-weeks treatment period), it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).
Intervention Type
Drug
Intervention Name(s)
Ethosuximide
Intervention Description
The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
Primary Outcome Measure Information:
Title
30% reduction in abdominal pain
Time Frame
through study completion, an average of 12 weeks.
Title
Score of 4 or 5 on the SGA scale
Time Frame
through study completion, an average of 12 weeks.
Secondary Outcome Measure Information:
Title
Monthly assessment of abdominal pain
Time Frame
at 1 month
Title
Monthly assessment of score of Bristol scale
Time Frame
at 1 month
Title
Monthly evaluation of GIQLI questionnaire
Time Frame
at 1 month
Title
Monthly evaluation of EQ-5D questionnaire
Time Frame
at 1 month
Title
Monthly evaluation of IBS-SSS questionnaire
Time Frame
at 1 month
Title
Monthly evaluation of SGA scale.
Time Frame
at 1 month
Title
Monthly evaluation of the use of analgesics
Time Frame
at 1 month
Title
Monthly evaluation of the use of antispasmodic
Time Frame
at 1 month
Title
Monthly evaluation of the use of regulators transit.
Time Frame
at 1 month
Title
Monthly evaluation of medical response rate
Time Frame
at 1 month
Title
Monthly evaluation of stop work related to IBS.
Time Frame
at 1 month
Title
Evaluation of the tolerance of ethosuximide throughout the study.
Time Frame
at 1 month
Title
Evaluation of the discontinuation rate study because of adverse events throughout the study
Time Frame
at 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, Man, Women, Negative pregnancy test and effective contraception, IBS defined by the Rome criteria IV During the previous seven days the inclusion visit, average NRS pain ≥ 4, IBS Treatment stable for 1 month Patients affiliated to the French Social Security, Patients with the informed consent were obtained. Exclusion Criteria: Breastfeeding Diabetic patients Known renal or hepatic impairment, Significant liver function abnormalities (transaminases> 3N, cholestasis) and renal (MDRD <60 ml / min) Addiction to alcohol and / or drugs, AEDs taken (epilepsy or chronic pain) chronic pain of greater intensity than that related to IBS, Allergy succinimides (ethosuximide, methsuximide, phensuximide) History or current severe depression (hospitalization, long-term antidepressant treatment) Psychotic disorders, Patients exclusion period, or total exceeded authorized allowances Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien SCANZI, MD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28720615
Citation
Kerckhove N, Scanzi J, Pereira B, Ardid D, Dapoigny M. 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. BMJ Open. 2017 Jul 18;7(7):e015380. doi: 10.1136/bmjopen-2016-015380.
Results Reference
derived

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Ethosuximide to Treat IBS

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