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Recruiting NCT05575505

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

Phase II Interventional Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pentoxifylline 400 MG.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug Pentoxifylline 400 MG
    Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics

Primary outcome measures

  • changes in Mayo Score Index. [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Mansoura University — Al Mansurah

Identifiers

NCT: NCT05575505 · 11/2022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗