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NCT Number: NCT04217733

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

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

Recruiting

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

pentoxyifylline

Drug

Pentoxyifylline two times daily for 3 months

Mebeverine

Drug

Mebeverine 3 times for 3 months

Ethosuximide

Drug

ethosuximide 3 times for 3 months

Primary outcomes

  1. Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS

    Time frame: 6 months

    the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS

Study contacts

Contact information is provided by the study sponsor or research team.

Sherief Abd-Elsalam, ass. prof.

CONTACT

[email protected]

00201147773440

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 3, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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