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

January 2, 2020 updated by: Sherief Abd-Elsalam, Tanta University

A Comparative Study to Assess Safety and Effectiveness of 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mebeverine
Mebeverine 3 times daily for 3 months
Drug: Mebeverine
Mebeverine 3 times for 3 months
Experimental: Ethosuximide
Ethosuxemide 3 times daily for 3 months
Drug: ethosuximide
ethosuximide 3 times for 3 months
Experimental: Pentoxyifylline
pentoxyifylline 2 times daily for 3 months
Drug: pentoxyifylline
Pentoxyifylline two times daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Mostafa Mahmoud Bahaa El dien, Msc, Clinical Pharmacy department
  • Principal Investigator: Sahar El-Haggar, Prof, Clinical pharmacy Department- Tanta University
  • Principal Investigator: Sahar Hegazy, Prof., Clinical pharmacy Department- Tanta University
  • Principal Investigator: Sherief Abd-Elsalam, Ass. Prof., Tropical Medicine Department- Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 30, 2030

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sherief Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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