NCT05684484

Role of Roflumilast in Ulcerative Colitis

Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .

Detailed description

* Study design and study population This study will be randomized, controlled, parallel study. * It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months * Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. * A written informed consent will be obtained from all patients * This study will be approved by the Research Ethics Committee of Tanta University. * Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form . * Randomization will be carried out based on days of hospital admission

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Roflumilast 500 MCG Oral Tablet [DALIRESP]	Roflumilast has been approved by U.S. Food and Drug Administration (FDA) for attenuating bronchial and dermatological disorders
DRUG	amino salicylic acid	conventional treatment

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-04-15
• Completion: 2024-09-15
• First posted: 2023-01-13
• Last updated: 2025-01-28

Locations

1 site across 1 country: Egypt