Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 46
- 主要终点
- Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire .
研究概览
简要总结
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Control group (Mesalamine group)
Control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 3 months.
干预措施: Mesalamine (Drug)
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.
干预措施: Febuxostat (Drug)
结局指标
主要结局
Health-related quality of life (HRQOL) using the short inflammatory bowel disease questionnaire .
时间窗: 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
Assessment of disease activity using Partial Mayo Scoring Index (PMSI) assessment for Ulcerative Colitis Activity.
时间窗: 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.
次要结局
未报告次要终点
研究者
Abdelrahman Mohammed El-kabbary Hasan Diab
Principal Investigator
Tanta University