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AzTrials

Irritable Bowel SyndromePhase 2IBSETNCT02973542

Ethosuximide to Treat IBS

A Phase 2 study testing Ethosuximide in people with Irritable Bowel Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Ethosuximide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
1 siteFrance
Study dates
8 Feb 2018to 7 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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 ...).

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: Evaluation of the Efficacy and Tolerance of Ethosuximide in the Treatment of Abdominal Pain Associated With Irritable Bowel Syndrome

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.

Read the 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.

Being tested
Ethosuximide, Placebo
Keywords
IBS, Ethosuximide, Pain
Medical subject headings
Irritable Bowel Syndrome, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EthosuximideDrug

    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.

  • PlaceboOther

    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.

Study groups in NCT02973542
Study groupRoleWhat they receive
ethosuximideExperimentalA 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).
Receives: Drug: Ethosuximide
placeboPlacebo comparatorA 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).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30% reduction in abdominal pain

    Measured: through study completion, an average of 12 weeks.

  2. Score of 4 or 5 on the SGA scale

    Measured: through study completion, an average of 12 weeks.

Secondary outcomes (13)

  1. Monthly assessment of abdominal pain

    Measured: at 1 month

  2. Monthly assessment of score of Bristol scale

    Measured: at 1 month

  3. Monthly evaluation of GIQLI questionnaire

    Measured: at 1 month

  4. Monthly evaluation of EQ-5D questionnaire

    Measured: at 1 month

  5. Monthly evaluation of IBS-SSS questionnaire

    Measured: at 1 month

  6. Monthly evaluation of SGA scale.

    Measured: at 1 month

  7. Monthly evaluation of the use of analgesics

    Measured: at 1 month

  8. Monthly evaluation of the use of antispasmodic

    Measured: at 1 month

  9. Monthly evaluation of the use of regulators transit.

    Measured: at 1 month

  10. Monthly evaluation of medical response rate

    Measured: at 1 month

  11. Monthly evaluation of stop work related to IBS.

    Measured: at 1 month

  12. Evaluation of the tolerance of ethosuximide throughout the study.

    Measured: at 1 month

  13. Evaluation of the discontinuation rate study because of adverse events throughout the study

    Measured: at 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study start8 Feb 2018
  3. Primary completion7 Mar 2023
  4. Study completion7 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973542
Sponsor's protocol ID
CHU-289
Other IDs
2016-002110-42, 2016
Acronym
IBSET
Status last verified
Apr 2026
First submitted
18 Nov 2016
Last updated
21 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kerckhove N, Zerbib F, Chambaz M, Mion F, Zalar A, Goutorbe F, Coffin B, Payen L, Roman S, Guilngar A, Pereira B, Duale C, Dapoigny M, Melchior C, Scanzi J; IBSET Investigator Group (IIG). Ethosuximide and Irritable Bowel Syndrome-Related Abdominal Pain: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551368. doi: 10.1001/jamanetworkopen.2025.51368.

    PubMed 41505133

  • 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.

    PubMed 28720615

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ethosuximide in people with Irritable Bowel Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30% reduction in abdominal pain (time frame: through study completion, an average of 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973542, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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