Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine

July 24, 2024 updated by: Abdelrahman Mohammed El-kabbary Hasan Diab, Tanta University
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ulcerative colitis (UC) is a sub-category of inflammatory bowel diseases (IBD) that causes mucosal inflammation in the rectum and lower colon. Although the exact pathogenesis of ulcerative colitis remains unclear, potential risk factors include altered immune responses, overactive immune response toward commensal microflora, genetic susceptibility, and environmental factors that have been considered as potential risk factors for UC .

The pathogenesis of UC consists of immuno-inflammatory pathways related to the multiple components of the intestine, including the epithelial barrier, dysregulation of immunological responses, leukocyte recruitment, and genetic factors. The understanding of immuno-inflammatory pathways of UC might lead to the development of a specific therapy and/or a novel treatment that could be more efficient .

Mesalazine (also known as mesalamine or 5- amino salicylic acid, 5-ASA) has a well-established role in UC management. It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC. The mechanism of action of mesalazine is diverse. It acts locally on colonic mucosa and reduces inflammation by several anti-inflammatory processes .

Febuxostat (FXT) is a medication used in management hyperuricemia espicially in gout, a condition characterized by joints pain as result of deposition of uric acid crystals due to elevated urate blood levels. It's a non-purine selective xanthine oxidase inhibitor. Xanthin oxidase is an enzyme that plays a main role in production of uric acid from xanthine and hypoxanthine.

Furthermore, there is no need for dose modification of FXT in case of renal impairment and so it's great choice for many patients as it may exhibit renal protective effect and delay progression of kidney injury and according to Zhou H et al. FXT appears to be well tolerated in healthy population who has normal serum uric acid levels with no serious adverse events were reported .

Lately, febuxostat's spectrum of use has expanded over hyperuricemia management as result of it's ability of amelioration oxidative stress and regulation inflammatory response due to pro -inflammatory cytokines modulation.

Keyvan Amirshahrokhi and El-Mahdy NA et al. inspected the potential of FXT in mitigating ulcerative colitis in mice. The findings from those studies suggest that febuxostat may exert anti- inflammatory effects in the context of ulcerative colitis. Febuxostat's anti- inflammatory effects in ulcerative colitis may be linked to its inhibition of the nuclear factor kappa B (NF-κB) signaling pathway, a key regulator of inflammation. This inhibition can reduce the production of proinflammatory cytokines, contributing to its anti-inflammatory properties .

Although, preclinical studies in animal models are promising, translating these results into clinical applications is necessary to evaluate the safety and efficacy of FXT in managing UC in human.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdelrahman Mohammed Elkabbary Hasan Diab
  • Phone Number: 002 01102400485
  • Email: alabbary99@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (Mesalamine group)
Control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 3 months.
Drug: Mesalamine
1 g mesalamine three times daily for 3 months.
Experimental: Experimental group (Febuxostat group)
Experimental group (Febuxostat group, n = 23) which will receive the standard treatment for UC plus 40 mg febuxostat once daily for 3 months.
Drug: Febuxostat
40mg of Febuxostat once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity.
Time Frame: 3 months
It depends on three items: stool frequency, rectal bleeding (blood in stool) and Physician's Global Assessment. Each item has a score from 0 to 3 and total PMSI is the sum of scores for the three items.
3 months
Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire .
Time Frame: 3 months
Short Inflammatory Bowel Disease Ques-tionnaire (SIBDQ) version became widely known and is currently used worldwide both in clinical practice and clinical research. SIBDQ comprises a total of 10 questions grouped into four different dimensions: social, bowel, emotional, and systemic [6, 7]. Each question is scored by a 7-point Likert scale, ranging from 1 (a severe problem) to 7 (not a problem at all), giving an absolute SIBDQ score ranging from 10 (poor HRQoL) to 70 (opti-mal HRQoL). A SIBDQ score below 50 was considered as poor QoL.there are no validated cut-offs for the dif-ferent dimensions' scores. Hence, higher scores indicate a better HRQoL concerning that specific domain.Although patient-reported outcomes are highly valu-able for better patient care, patient responses to HRQoL instruments can be impacted by underlying cultural trends
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.24.04.2758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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