Clinical trial NCT04217733: 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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,

Primary outcomes:
measure: Number of patients with improved Visual analog scales (VAS) for assessment of pain in IBS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Clinical Pharmacy department
name: Mostafa Mahmoud Bahaa El dien, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical pharmacy Department- Tanta University
name: Sahar El-Haggar, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical pharmacy Department- Tanta University
name: Sahar Hegazy, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tropical Medicine Department- Tanta University
name: Sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.