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
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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