Assessment of Empagliflozin as Adjuvant Therapy in Patien... | NCT05058417

Studies
Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis

NCT05058417

Sponsor

Sadat City University

Status

Withdrawn

Last Update Posted

Jul 14, 2025Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Ulcerative Colitis

Interventions

Empagliflozin 10 MG
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Institutional and funding constrains

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Sep 16, 2021

First Submission Date that Met QC Criteria

Sep 16, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2025

Last Update Posted Date

Jul 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empagliflozin group	Experimental	participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy	Drug: Empagliflozin 10 MG
Placebo	Placebo Comparator	participants will receive placebo for 8 consecutive weeks in addition to the standard therapy	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin 10 MG	Drug	participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy	Empagliflozin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of colonic (NF)-κB proteins	Difference between the two groups in the expression of colonic (NF)-κB proteins.	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Pharmacy		Shibīn al Kawm	Menoufia	13829	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided