Skip to main content
OpenTrials
Completed

NCT Number: NCT05558761

Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentoxifylline 400 MG

Drug

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

Primary outcomes

  1. Improvement in health related quality of life

    Time frame: 6 months

    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

Secondary outcomes

  1. changes in the level of measured biomarkers.

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.