Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Early Phase 1 · Testing Empagliflozin and conventional treatment · 1 site · Tanta University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Empagliflozin (a drug) and conventional treatment (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- •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…
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2023-01-01.
- Main results expected around 2025-12-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Egypt.
Main thing being measured
- clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. (4months)
In the researchers’ words
•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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Tanta University |
| Enrollment | 60 (estimated) |
| Start date | 2023-01-01 |
| Primary completion (est.) | 2025-12-01 |
| First posted | 2022-11-09 |
| Last updated | 2025-07-16 |
| Official title | Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT05610956 |
Interventions
- Empagliflozin (Drug)
Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months. - conventional treatment (Drug)
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
Full eligibility criteria (from the record)
Inclusion Criteria: •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. Exclusion Criteria: * Other inflammatory bowel diseases (CD). * History of serious hypersensitivity to empagliflozin or any component of the formulation. * Patients on dialysis. * Severe renal impairment (eGFR <20 ml/minute/1.73m2) . * Chronic urinary tract infection. * Chronic genital infection.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. | Tanta | Egypt | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.