Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

NCT05558761 | Completed Phase 2

• 1 other identifier: 3455
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• changes in the level of measured biomarkers.

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

this group will take mesalamine 1 g three times daily

Pentoxifylline group

ACTIVE COMPARATOR

his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily

Drug: Pentoxifylline 400 MG

Interventions

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

Pentoxifylline group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (1)

• Bahaa MM, Hegazy SK, Maher MM, Bahgat MM, El-Haggar SM. Pentoxifylline in patients with ulcerative colitis treated with mesalamine by modulation of IL-6/STAT3, ZO-1, and S1P pathways: a randomized controlled double-blinded study. Inflammopharmacology. 2024 Oct;32(5):3247-3258. doi: 10.1007/s10787-024-01560-6. Epub 2024 Aug 27.

  PMID: 39192162 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mostafa M Bahaa, PhD

  Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 28, 2022
• Study Start: October 10, 2022
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

EG (1)