RecruitingEarly Phase 1NCT05610956

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


Sponsor

Tanta University

Enrollment

60 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • •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 Criteria6

  • 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.

Interventions

DRUGEmpagliflozin

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.

DRUGconventional 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05610956


Related Trials