Role of Roflumilast in Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tanta University
• Treatments: Salicylates; Salicylic Acid

Criteria

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 )