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NCT05058417 Clinical Trial

Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05058417
Other study ID # G12/2021
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2025

Study information
Verified date November 2023
Source Sadat City University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Empagliflozin 10 MG
participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
• Placebo
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy

Locations
Country Name City State
Egypt Faculty of Pharmacy Shibin Al Kawm Menoufia

Sponsors (1)
Lead Sponsor Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Expression of colonic (NF)-?B proteins Difference between the two groups in the expression of colonic (NF)-?B proteins. 8 weeks
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