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Clinical Trials in Egypt / NCT05610956
Recruiting Early Phase 1

Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

NCT05610956 · tracked via the Priya Life Science Egypt tracker
Sponsor
Tanta University
Phase
Early Phase 1
Started
2023-01-01
Last updated
2025-07-16

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Empagliflozin →conventional treatment

Empagliflozin: Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.

conventional treatment: conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

Study summary

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: •Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis. Exclusion Criteria: * Other inflammatory bowel diseases (CD). * History of serious hypersensitivity to empagliflozin or any component of the formulation. * Patients on dialysis. * Severe renal impairment (eGFR \<20 ml/minute/1.73m2) . * Chronic urinary tract infection. * Chronic genital infection.

Primary outcome measure(s)

  • clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. — 4months
    difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

Trial sites (1)

FacilityCityRegionStatus
Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. Tanta Egypt Recruiting

On this site

📄 Jardiance (empagliflozin) drug profile →

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Other trials for the same condition

Desloratadine in Patients With Ulcerative Colitis Recruiting
Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine Recruiting
Nitazoxanide in Patients With Ulcerative Colitis Recruiting
Beneficial Effect of Silymarin in Ulcerative Colitis Recruiting
Rupatadine in Patients With Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05610956 on ClinicalTrials.gov ↗ ← All trials in Egypt