Role of Roflumilast in Ulcerative Colitis

Sponsor
Tanta University
Study ID
NCT05684484
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 1, 2023
Status verified
Jan 2025
Primary completion
Apr 15, 2024
Completion
Sep 15, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: mesalamine group
    Placebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months.
  • Experimental: Roflumilast group
    Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months

Primary Outcome Measure

clinical improvement in ulcerative colitis severity [ Time Frame: 3 months ]

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