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

T

Tanta University

Status and phase

Enrolling
Phase 3

Conditions

IBS - Irritable Bowel Syndrome

Treatments

Drug: ethosuximide
Drug: pentoxyifylline
Drug: Mebeverine

Study type

Interventional

Funder types

Other

Identifiers

NCT04217733
Sherief Protocol

Details and patient eligibility

About

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

Full description

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

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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,

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 3 patient groups

Mebeverine
Active Comparator group
Description:
Mebeverine 3 times daily for 3 months
Treatment:
Drug: Mebeverine
Ethosuximide
Experimental group
Description:
Ethosuxemide 3 times daily for 3 months
Treatment:
Drug: ethosuximide
Pentoxyifylline
Experimental group
Description:
pentoxyifylline 2 times daily for 3 months
Treatment:
Drug: pentoxyifylline

Trial contacts and locations

1

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Central trial contact

Sherief Abd-Elsalam, ass. prof.

Data sourced from clinicaltrials.gov

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