Role of Roflumilast in Ulcerative Colitis

Overview

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

Full Title of Study: “Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: February 2024

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

Interventions

• Drug: Roflumilast 500 Ug ORAL TABLET [Daliresp]
  • Roflumilast has been approved by U.S. Food and Drug Administration (FDA) for attenuating bronchial and dermatological disorders
• Drug: corticosteroids +immune suppressive +amino salicylic acid
  • conventional treatment

Arms, Groups and Cohorts

• Active Comparator: conventional treatment group
  • Group 1 (n=26): Patients will receive conventional treatment only of ulcerative colitis for 3 months.
• Experimental: experimental treatment group
  • Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months

Clinical Trial Outcome Measures

Primary Measures

• 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

Secondary Measures

• changes in serum levels of the measured biochemical parameters
  • Time Frame: 7 months
  • demonstrate changes in serum levels of the measured biochemical parameters Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA). Signal transducer and activator of transcription 3 (STAT3) as a potential marker for apoptosis ( ELISA) Caspase-3 as a potential marker for apoptosis (ELISA).

Participating in This Clinical Trial

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 )

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Tanta University
• Provider of Information About this Clinical Study
  • Principal Investigator: ahmed magdy youness, clinical pharmacist – Tanta University
• Overall Contact(s)
  • ahmed m. youness, master degree, 0020114718892, ahmedyounes881@gmail.com

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