Role of Roflumilast in Ulcerative Colitis

Tanta University

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: amino salicylic acid; Drug: Roflumilast 500 MCG Oral Tablet [DALIRESP]

Study type: Interventional

Funder types: Other

Identifiers

NCT05684484

Roflumilast ulcerative colitis

Details and patient eligibility

About

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

Full 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

Enrollment: 52 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: Accepts Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

mesalamine group

Placebo Comparator group

Description:

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

Treatment:

Drug: amino salicylic acid

Roflumilast group

Experimental group

Description:

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

Treatment:

Drug: Roflumilast 500 MCG Oral Tablet [DALIRESP]