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Not Yet Recruiting NCT05684484

Role of Roflumilast in Ulcerative Colitis

Conditions: Ulcerative Colitis

Sex: All
Ages: 15 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 52
Sponsor: Tanta University

Summary

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

Eligibility 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: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.Exclusion Criteria:Other inflammatory bowel disease (crohn's disease) .Patients <15 and >80 yearsPatients who didn't give consent to participate in the studyPatients 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 excludedHistory 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 )

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05684484). StuddyBuddy aggregates publicly available trial information.