NCT04217733

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
57mo left

Started Nov 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Nov 2019Dec 2030

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

11.1 years

First QC Date

December 29, 2019

Last Update Submit

January 2, 2020

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Mebeverine

ACTIVE COMPARATOR

Mebeverine 3 times daily for 3 months

Drug: Mebeverine

Ethosuximide

EXPERIMENTAL

Ethosuxemide 3 times daily for 3 months

Drug: ethosuximide

Pentoxyifylline

EXPERIMENTAL

pentoxyifylline 2 times daily for 3 months

Drug: pentoxyifylline

Interventions

pentoxyifyllineDRUG

Pentoxyifylline two times daily for 3 months

Pentoxyifylline
MebeverineDRUG

Mebeverine 3 times for 3 months

Mebeverine
ethosuximideDRUG

ethosuximide 3 times for 3 months

Ethosuximide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years,
  • Man and Women, Negative pregnancy test and effective contraception,
  • IBS defined by the Rome criteria IV
  • IBS Treatment stable for 1 month

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35221706DERIVED

  • 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.

    PMID: 34726293DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

mebeverineEthosuximide

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

SuccinimidesImidesOrganic ChemicalsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 3, 2020

Study Start

November 1, 2019

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

January 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)