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

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
pentoxyifylline
Mebeverine
ethosuximide
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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,

Sites / Locations

  • Sherief Abd-ElsalamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Mebeverine

Ethosuximide

Pentoxyifylline

Arm Description

Mebeverine 3 times daily for 3 months

Ethosuxemide 3 times daily for 3 months

pentoxyifylline 2 times daily for 3 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 29, 2019
Last Updated
January 2, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04217733
Brief Title
Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mebeverine
Arm Type
Active Comparator
Arm Description
Mebeverine 3 times daily for 3 months
Arm Title
Ethosuximide
Arm Type
Experimental
Arm Description
Ethosuxemide 3 times daily for 3 months
Arm Title
Pentoxyifylline
Arm Type
Experimental
Arm Description
pentoxyifylline 2 times daily for 3 months
Intervention Type
Drug
Intervention Name(s)
pentoxyifylline
Intervention Description
Pentoxyifylline two times daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Mebeverine
Intervention Description
Mebeverine 3 times for 3 months
Intervention Type
Drug
Intervention Name(s)
ethosuximide
Intervention Description
ethosuximide 3 times for 3 months
Primary Outcome Measure Information:
Title
Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
Description
the number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mostafa Mahmoud Bahaa El dien, Msc
Organizational Affiliation
Clinical Pharmacy department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar El-Haggar, Prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahar Hegazy, Prof.
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Organizational Affiliation
Tropical Medicine Department- Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Phone
00201009221243
Email
sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35221706
Citation
El-Haggar SM, Hegazy SK, Abd-Elsalam SM, Elkaeed EB, Al-Karmalawy AA, Bahaa MM. A Potential Role of Ethosuximide and Pentoxifylline in Relieving Abdominal Pain in Irritable Bowel Syndrome Patients Treated with Mebeverine: A Randomized, Double-Blind, Placebo-Controlled Trial. J Inflamm Res. 2022 Feb 19;15:1159-1172. doi: 10.2147/JIR.S346608. eCollection 2022.
Results Reference
derived
PubMed Identifier
34726293
Citation
El-Haggar SM, Hegazy SK, M Abd-Elsalam S, Bahaa MM. Open-label pilot study of ethosuximide as adjunctive therapy for relieving abdominal pain related to Irritable Bowel Syndrome. J Clin Pharm Ther. 2022 Mar;47(3):306-312. doi: 10.1111/jcpt.13556. Epub 2021 Nov 2.
Results Reference
derived

Learn more about this trial

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

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