Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Sadat City University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Ulcerative Colitis

Interventions

Empagliflozin 10 MGDRUG

participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy

PlaceboDRUG

participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Pharmacy

Shibīn al Kawm, Menoufia, Egypt

Outcomes

Primary Outcomes

Expression of colonic (NF)-κB proteins

Difference between the two groups in the expression of colonic (NF)-κB proteins.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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