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Recruiting NCT04217733

Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Phase III Interventional IBS - Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pentoxyifylline, Mebeverine, ethosuximide.
Who it may be relevant to
Registry conditions: IBS - Irritable Bowel Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study to Assess Safety and Effectiveness of Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome

Overview

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome

Detailed description

Ethosuximide and pentoxifylline in the treatment of abdominal pain related to irritable bowel syndrome: Does this add to current treatment?

Interventions

  • Drug pentoxyifylline
    Pentoxyifylline two times daily for 3 months
  • Drug Mebeverine
    Mebeverine 3 times for 3 months
  • Drug ethosuximide
    ethosuximide 3 times for 3 months

Primary outcome measures

  • Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • • Age ≥ 18 years,
  • Man and Women, Negative pregnancy test and effective contraception,
  • IBS defined by the Rome criteria IV
  • During the previous seven days the inclusion visit, average numeric rating scale (NRS) pain ≥ 4.
  • IBS Treatment stable for 1 month

Exclusion criteria

  • • Breastfeeding
  • Diabetic patients
  • Significant liver function abnormalities (transaminases> 3N, cholestasis) and moderate renal disease (MDRD <60 ml / min)
  • Addiction to alcohol and / or drugs,
  • Antiepileptic drugs taken (epilepsy or chronic pain)
  • Chronic pain of greater intensity than that related to IBS,
  • Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline.
  • History or current severe depression (hospitalization, long-term antidepressant treatment)
  • Psychotic disorders,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sherief Abd-Elsalam — Tanta

Publications

  • El-Haggar SM, Hegazy SK, Abd-Elsalam SM, Elkaeed EB, Al-Karmalawy AA, Bahaa MM. A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022. PMID 35221706
  • El-Haggar SM, Hegazy SK, M Abd-Elsalam S, Bahaa MM. Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome. J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2. PMID 34726293

Identifiers

NCT: NCT04217733 · Sherief Protocol

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗