Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05058417
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sadat City University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Experimental: Empagliflozin group

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

Placebo Comparator: Placebo

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

Interventions

Drug: - Empagliflozin 10 MG

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

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Faculty of Pharmacy, Shibīn Al Kawm, Menoufia, Egypt

Status

Recruiting

Address

Faculty of Pharmacy

Shibīn Al Kawm, Menoufia, 13829

Site Contact

Mahmoud S Abdallah, PhD

Mahmoud.samy@fop.usc.edu.eg

01063340887

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