Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
Early Phase 1 · Testing Febuxostat and Mesalamine · Sites not listed yet · Tanta University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Febuxostat (a drug) and Mesalamine (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
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 and older
- Any sex
Some of the main requirements, copied from the record:
- Age ≥ 18 years old.
- Both male and female will be included.
- Mild and moderate UC patients diagnosed and confirmed by endoscope.
Plus 1 more requirement(s). There are also 16 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 46 participants are expected to take part.
- Start date: 2024-09-01 (planned).
- Main results expected around 2026-09-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity. (3 months)
In the researchers’ words
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.
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 | Not yet recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Tanta University |
| Enrollment | 46 (estimated) |
| Start date | 2024-09-01 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2024-07-29 |
| Last updated | 2024-07-29 |
| Official title | Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine |
| ClinicalTrials.gov ID | NCT06525974 |
Interventions
- Febuxostat (Drug)
40mg of Febuxostat once daily - Mesalamine (Drug)
1 g mesalamine three times daily for 3 months.
Full eligibility criteria (from the record)
Inclusion Criteria: * Age ≥ 18 years old. * Both male and female will be included. * Mild and moderate UC patients diagnosed and confirmed by endoscope. * Patient treated with 5-aminosalislic acid (mesalamine). Exclusion Criteria: * Patients with severe UC. * Significant liver and kidney function abnormalities. * Diabetic patients. * Patients with Colorectal cancer patients. * Patients taking rectal or systemic steroids. * Patients on immunosuppressants or biological therapies. * Addiction to alcohol and / or drugs. * Known allergy to the studied medications. * History of complete or partial colectomy. * Patients with congestive heart failure, other heart disease (Arrhythmia, ischemic heart disease including angina and myocardial infarction). * Patients with other inflammatory diseases and active infection. * Patients with stressful condition (COPD, morbid obesity). * Patients with liver disease. * Patients with thrombocytopenia and neutropenia. * Pregnant or lactating females. * Patients were treated with mercaptopurine.
Locations (0)
No sites listed yet. The official record has contact information.
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.