Assessment of Empagliflozin as Adjuvant Therapy in Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Expression of colonic (NF)-κB proteins
研究概览
简要总结
This is a randomized, controlled study evaluating empagliflozin tablets administered daily for 8 weeks. The purpose of the study is to evaluate the efficacy and safety of empagliflozin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using Mayo score for ulcerative colitis activity. Calculation of the score requires patients to undergo colonoscopy at the start of the study and at week 8.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild or moderate ulcerative colitis newly diagnosed by colonoscopy and biopsy according to Mayo endoscopic scoring of ulcerative colitis.
- •Adults (males and/or females) with age range from 18 to 65 years old.
- •Patients on treatment with 5-aminosalisylic acid (5-ASA)
排除标准
- •Patients with severe ulcerative colitis according to Mayo endoscopic scoring of ulcerative colitis.
- •Treatment with systemic or rectal steroids.
- •Treatment with immunosuppressants.
- •Previously failed treatment with a sulphasalazine.
- •Known hypersensitivity to any of study drugs.
- •Hepatic and renal dysfunction.
- •Pregnancy and lactation.
- •History of colorectal carcinoma.
- •History of complete or partial colectomy.
- •Patients with diabetes mellitus
- •Patients with history of lactic acidosis
- •Patients with disease states associated with hypoxemia including cardiorespiratory insufficiency
- •Positive stool culture for enteric pathogens, positive stool ova and parasite exam.
研究组 & 干预措施
Empagliflozin group
participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
干预措施: Empagliflozin 10 MG (Drug)
Placebo
participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
干预措施: Placebo (Drug)
结局指标
主要结局
Expression of colonic (NF)-κB proteins
时间窗: 8 weeks
Difference between the two groups in the expression of colonic (NF)-κB proteins.
次要结局
未报告次要终点
研究者
Mahmoud Samy Abdallah
Principle Investigator
Sadat City University