Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Sadat City University

Status and phase

Withdrawn

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: Empagliflozin 10 MG

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05058417

G12/2021

Details and patient eligibility

About

This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
Adults (males and/or females) with age range from 18 to 65 years old.
Patients on treatment with 5-aminosalisylic acid (5-ASA)

Exclusion criteria

Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
Treatment with systemic or rectal steroids.
Treatment with immunosuppressants.
Previously failed treatment with a sulphasalazine.
Known hypersensitivity to any of study drugs.
Hepatic and renal dysfunction.
Pregnancy and lactation.
History of colorectal carcinoma.
History of complete or partial colectomy.
Patients with diabetes mellitus
Patients with history of lactic acidosis
Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
Positive stool culture for enteric pathogens, positive stool ova and parasite exam.