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

Phase 3

Recruiting

• Conditions: IBS - Irritable Bowel Syndrome
• Interventions: Drug: Mebeverine; Drug: ethosuximide; Drug: pentoxyifylline

• Registration Number: NCT04217733
• Lead Sponsor: Tanta University

Brief Summary

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?

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-12-29
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-02
• Last Update Submitted: 2020-01-02
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2030-12-01
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mebeverine	Mebeverine	Mebeverine 3 times daily for 3 months
Ethosuximide	ethosuximide	Ethosuxemide 3 times daily for 3 months
Pentoxyifylline	pentoxyifylline	pentoxyifylline 2 times daily for 3 months

Primary Outcome Measures

Name	Time	Method
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS	6 months	the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt