Role of Roflumilast in Ulcerative Colitis

NCT05684484 | Completed Phase 4

• 1 other identifier: Roflumilast ulcerative colitis
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• clinical improvement in ulcerative colitis severity

  To demonstrate the efficacy of Roflumilast and clinical improvement in (Mayo disease activity index) for assessment of ulcerative colitis severity

  3 months

Secondary Outcomes (1)

• changes in serum levels of the measured biochemical parameters

  7 months

Study Arms (2)

mesalamine group

PLACEBO COMPARATOR

Placebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months.

Drug: amino salicylic acid

Roflumilast group

EXPERIMENTAL

Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months

Drug: Roflumilast 500 MCG Oral Tablet [DALIRESP]

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

Also known as: phosphodiesterase type 4

Roflumilast group

amino salicylic acid DRUG

conventional treatment

Also known as: mesalamine

mesalamine group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to endoscopy units in Tanta University hospitals during the period of the study.
• Patient with mild to moderate UC diagnosed as:
• 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.
• Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of pharmacy Tanta university

Tanta, 002, Egypt

Location

Related Publications (16)

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MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Roflumilast; Tablets; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Model Details: It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Placebo Group (n=26): Patients will receive conventional tratment only (amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: April 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

EG (1)