Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05558761

Collaborator

(none)

Enrollment

Location

Arms

28.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Pentoxifylline 400 MG	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double-blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 10, 2022

Anticipated Primary Completion Date :

Oct 20, 2024

Anticipated Study Completion Date :

Feb 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group this group will take mesalamine 1 g three times daily
Active Comparator: Pentoxifylline group his group will take mesalamine 1 g three times daily plus pentoxifylline 400 mg two times daily	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

Arm

Intervention/Treatment

No Intervention: Control Group

this group will take mesalamine 1 g three times daily

Active Comparator: Pentoxifylline group

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

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

Outcome Measures

Primary Outcome Measures

Improvement in health related quality of life [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 Outcome Measures

changes in the level of measured biomarkers. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Mansoura University	Mansoura		Egypt	35511

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: Mostafa M Bahaa, PhD, Pharmacy Practice Department, Faculty of Pharmacy, Horus University, New Damietta, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching Assistant, Tanta University

ClinicalTrials.gov Identifier:

NCT05558761

Other Study ID Numbers:

3455

First Posted:

Sep 28, 2022

Last Update Posted:

Nov 1, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Pentoxifylline

Study Results

No Results Posted as of Nov 1, 2022