Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.
1 other identifier
interventional
44
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedMarch 4, 2025
March 1, 2025
3 years
October 8, 2022
March 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Control Group
NO INTERVENTIONMesalamine group, who will receive 1 g mesalamine three times daily for 6 months.
Pentoxifylline group
ACTIVE COMPARATORThe pentoxifylline group will receive 1 g mesalamine three times daily plus pentoxifylline 400 mg two times daily for 6 months.
Interventions
Pentoxifylline (PTX) is a methyl-xanthine derivative that possesses antioxidant and anti-inflammatory characteristics
Eligibility Criteria
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
- Patients taking immunosuppressives or biological therapies
- Addiction to alcohol and / or drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Medicine, Mansoura University
Al Mansurah, 35511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
October 8, 2022
First Posted
October 12, 2022
Study Start
February 2, 2023
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
March 4, 2025
Record last verified: 2025-03