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NCT04217733 Clinical Trial

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

IBS - Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04217733
Other study ID # Sherief Protocol
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2019
Est. completion date December 30, 2030

Study information
Verified date January 2020
Source Tanta University
Contact Sherief Abd-Elsalam, ass. prof.
Phone 00201147773440
Email sheriefabdelsalam@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 30, 2030
Est. primary completion date December 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Sherief Abd-Elsalam Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS 6 months
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