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Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Placebo
Sponsored by
Sadat City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of PharmacyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Empagliflozin group

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2021
Last Updated
October 25, 2022
Sponsor
Sadat City University
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1. Study Identification

Unique Protocol Identification Number
NCT05058417
Brief Title
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
Official Title
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sadat City University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin group
Arm Type
Experimental
Arm Description
participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
Primary Outcome Measure Information:
Title
Expression of colonic (NF)-κB proteins
Description
Difference between the two groups in the expression of colonic (NF)-κB proteins.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Faculty of Pharmacy
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
13829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S Abdallah, PhD
Phone
01063340887
Email
Mahmoud.samy@fop.usc.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

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