Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Empagliflozin group

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

Group Type EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Empagliflozin 10 MG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No