Rupatadine in Patients With Ulcerative Colitis
Phase 2 · Testing Mesalamine and Rupatadine · 1 site · Alexandria University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Mesalamine (a drug) and Rupatadine (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- Age ≥ 18 years
- Both male and female will be included
- Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.
There are also 7 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: 2025-07-15.
- Main results expected around 2026-07-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Egypt.
Main thing being measured
- change in partial mayo score (3 months)
In the researchers’ words
Ulcerative colitis (UC) is a chronic inflammatory condition that primarily targets the large intestine. Although substantial progress has been made in treatment modalities-especially with the development of immunomodulatory drugs and biologic therapies-managing UC continues to present significant challenges.
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 | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Alexandria University |
| Collaborators | Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.; Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.; Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University. |
| Enrollment | 60 (estimated) |
| Start date | 2025-07-15 |
| Primary completion (est.) | 2026-07-15 |
| First posted | 2025-07-15 |
| Last updated | 2025-11-19 |
| Official title | Clinical Study to Evaluate Safety and Efficacy of Rupatadine in Patients With Ulcerative Colitis. |
| ClinicalTrials.gov ID | NCT07064707 |
Interventions
- Mesalamine (Drug)
Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management. - Rupatadine (Drug)
Rupatadine, a dual histamine H1 receptor and platelet-activating factor (PAF) receptor antagonist, has shown promising anti-inflammatory effects beyond its conventional use in allergic conditions
Full eligibility criteria (from the record)
Inclusion criteria: * Age ≥ 18 years * Both male and female will be included * Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology. Exclusion criteria: * Breast feeding or pregnancy. * Colorectal cancer patients. * Patients with severe UC. * Patients taking rectal or systemic steroids. * Patients taking immunosuppressives or biological therapies. * Addiction to alcohol and / or drugs. * Known allergy to the studied medications.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Alexandria University | Alexandria | 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.