Role of Roflumilast in Ulcerative Colitis

January 25, 2025 updated by: ahmed magdy youness, Tanta University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 002
        • Faculty of Pharmacy Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients referred to endoscopy units in Tanta University hospitals during the period of the study.

Patient with mild to moderate UC diagnosed as:

  1. Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss.
  2. Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion Criteria:

  • Other inflammatory bowel disease (crohn's disease) .
  • Patients <15 and >80 years
  • Patients who didn't give consent to participate in the study
  • Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded
  • History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness .
  • Depression , thoughts of suicide , anxiety and emotional instability .
  • Excessive weight loss .
  • Moderate to severe hepatic impairment (child pugh class B or C) .
  • Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction )
  • Loxapine ( Risk , X interaction )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: mesalamine group
Placebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months.
Drug: amino salicylic acid
conventional treatment
Other Names:
  • mesalamine
Experimental: Roflumilast group
Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months
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
Other Names:
  • phosphodiesterase type 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical improvement in ulcerative colitis severity
Time Frame: 3 months
To demonstrate the efficacy of Roflumilast and clinical improvement in (Mayo disease activity index) for assessment of ulcerative colitis severity
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in serum levels of the measured biochemical parameters
Time Frame: 7 months

demonstrate changes in serum levels of the measured biochemical parameters

  1. Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA).
  2. Signal transducer and activator of transcription 3 (STAT3) as a potential marker for apoptosis ( ELISA)
  3. Caspase-3 as a potential marker for apoptosis (ELISA).
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 25, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Roflumilast ulcerative colitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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