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

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Pentoxifylline 400 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05575505

11/2022

Details and patient eligibility

About

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• Patients taking immunosuppressives or biological therapies
• Addiction to alcohol and / or drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Control Group

No Intervention group

Description:

Mesalamine group, who will receive 1 g mesalamine three times daily for 6 months.

Pentoxifylline group

Active Comparator group

Description:

The pentoxifylline group will receive 1 g mesalamine three times daily plus pentoxifylline 400 mg two times daily for 6 months.

Treatment:

Drug: Pentoxifylline 400 MG