Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Recruiting · NCT05610956 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
•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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. - Tanta, Egypt