RECRUITINGEarly Phase 1INTERVENTIONAL
Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
About This Trial
•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 May Be Eligible (Plain English)
Who May Qualify:
•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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
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.
DRUG
conventional treatment
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
Locations (1)
Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.
Tanta, Egypt