Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.

Inflammatory Bowel Diseases Clinical Trial

Official title:

Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575505
• Other study ID #: 11/2022
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Also, it is associated with high risk of colon cancer, so there is a continuous need for introducing new therapies that decrease progression, and hence better outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• 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

• Patients taking immunosuppressives or biological therapies

• Addiction to alcohol and / or drugs

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

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	changes in Mayo Score Index.	The Mayo Score for ulcerative colitis disease activity assesses disease severity and can be used to monitor patients during therapy.; This scale uses four parameters to calculate the patient scores from 0-12. The parameters assessed are rectal bleeding, stool frequency, endoscopic findings, and physician assessment. Higher scores mean poor progression. Lower scores mean good progression	6 months