Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

Official title:

Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558761
• Other study ID #: 3455
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2022
• Est. completion date: February 20, 2025

Study information

• Verified date: January 2024
• Source: Tanta University
• Contact: Mostafa M Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 20, 2025
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Age = 18 years Both males and females will be included Negative pregnancy test and effective contraception

Exclusion Criteria:

• Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

Drug:
• Pentoxifylline 400 MG
Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics. PTX exerts anti-inflammatory effects by inhibiting phosphodiesterase and activating the adenosine 2 receptor

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in health related quality of life	Short Form 36 Health Survey (SF-36) will assess the quality of life. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability	6 months
Secondary	changes in the level of measured biomarkers.	changes in the level of measured biomarkers through assessment serum level of TNF- alpha, serum IL-10, and gene expression of zonula occuldin-1(ZO-1).	6 months