Tests empagliflozin in adults with mild to moderate ulcerative colitis
Tests empagliflozin alongside usual care in adults with mild to moderate ulcerative colitis.
Key facts
- Who runs it
- Tanta University
- Where
- Tanta, EgyptSee the site
- Trial code
- Registry title
- Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 60 people, planned
- Started
- 1 Jan 2023
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Empagliflozin
- conventional treatment
- Record updated
- 16 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild to moderate ulcerative colitis. It tests whether empagliflozin helps and is safe.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Mild to moderate ulcerative colitis, confirmed by history, clinical signs, endoscopy and biopsy, rated with the Montreal classification.
Main reasons for not taking part
- Other inflammatory bowel disease (Crohn's disease)
- Serious allergic reaction to empagliflozin or its ingredients
- On dialysis
- Severe kidney problems (eGFR <20 ml/minute/1.73m2)
- Long-lasting urinary tract or genital infection
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- •Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis
Who cannot take part
- Other inflammatory bowel diseases (CD)
- History of serious hypersensitivity to empagliflozin or any component of the formulation
- Chronic urinary tract infection
- Chronic genital infection
- Severe renal impairment (eGFR <20 ml/minute/1.73m2)
- Patients on dialysis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Egypt
- Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.Tanta, EgyptContact: Mohamed El Sarhan, LecturerTaking people
About the trial
What the trial wants to find out
•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.
The 2 groups in the trial
- placebo groupPlacebo, for comparison
Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
Treatment: conventional treatment
- empagliflozin groupTreatment being tested
Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.
Treatment: Empagliflozin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
- Plain-language title
- Tests empagliflozin in adults with mild to moderate ulcerative colitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05610956, who can take part
- Record updated
- 16 July 2025