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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217733
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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

Condition or disease Intervention/treatment Phase
IBS - Irritable Bowel Syndrome Drug: pentoxyifylline Drug: Mebeverine Drug: ethosuximide Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217733


Contacts
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam, Ass. Prof.    00201009221243    sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
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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
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04217733    
Other Study ID Numbers: Sherief Protocol
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Abdominal Pain
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Ethosuximide
Mebeverine
Anticonvulsants
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs