CTRI/2024/08/071932尚未招募3 期
Efficacy of amitriptyline in inducing remission in patients with mild to moderate ulcerative colitis: A double-blind, randomized placebo-controlled trial
Department of Gastroenterology AIIMS Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rates of clinical remission at 12 weeks, defined as SCCAI score ≤2 with all sub-scores ≤1 in both groups.
研究概览
简要总结
Amitriptyline is often used to treat somatic symptoms in IBD, but there is evidence that it has some anti-inflammatory effects which may explain its efficacy in improving symptoms of Ulcerative Colitis (UC). Currently, there is a paucity of quality evidence regarding the efficacy of anti-depressant medications in UC. Hence this study aims to explore the efficacy and safety of amitriptyline in patients with mild –moderate UC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are confirmed cases of mild to moderate Ulcerative Colitis as assessed by SCCAI score (3-9)
- •Endoscopically active disease (UCEIS more than 1) or fecal calprotectin more than 150 μg/g.
- •Age: 18 – 70 years
- •Patients who are on optimum dosage of oral (minimum 2.4 g per day) and topical 5-ASA agents, are oral steroid naïve or experienced (last dose more than 8 weeks prior) but not on Steroids.
- •Anti-TNF/Anti-integrin naïve or experienced (intolerant or non-responder) but last dose ≥2 months back.
- •Concomitant therapy allowed.
- •a. Topical steroid and topical 5-ASA therapy (if stable for last 2 weeks) b. Patients on stable doses of oral 5-ASA (5-amino salicylic acid) for past 2 weeks. c. Patients on stable doses of azathioprine for past 2 weeks. d. Patients on advanced therapy (stable doses of biologicals, tofacitinib or vedolizumab for past 8 weeks)
- •Women of childbearing age should agree to avoid conception during the study period.
- •Patients giving written informed consent.
排除标准
- •Severe disease SCCAI more than or equal to 10
- •Patients with fulminant colitis requiring hospitalization
- •Use of oral steroids, antibiotics, Anti-TNF/Anti-integrin agents, small molecule inhibitors within the past 8 weeks.
- •Patients with surgical intervention for IBD, on psychiatric medication or pregnant and lactating women
- •Patients with bipolar, psychotic, substance use disorders, major depressive disorder or anxiety disorders.
- •Cardiac: NYHA II or higher congestive heart failure b.
- •Renal: Creatine clearance (Cockcroft Gault formula) less than 40 ml/min c.
- •Severe hepatic impairment d.
- •Malignancies or a history of malignancies e.
- •History of bowel surgery within 6 months.
结局指标
主要结局
Rates of clinical remission at 12 weeks, defined as SCCAI score ≤2 with all sub-scores ≤1 in both groups.
时间窗: 12 weeks
次要结局
- Effect of amitriptyline versus placebo on the quality of life (WHOQOL BREF)
- 2. Clinical response at 12 weeks, defined as reduction in SCCAI score by ≥3 points or by 30% reduction in SCCAI score from baseline in both groups.(12 weeks)
- 3. Treatment failure, defined as increase in SCCAI score by more than or equal to 3 points with all sub scores more than or equal to 1 points.(12 weeks)
- 4. Endoscopic response and remission at 12 weeks defined as decline in UCEIS by 2 points and UCEIS of less than or equal to 1 points respectively points respectively.(12 weeks)
- 5. Deep remission at 12 weeks defined as a combination of clinical and endoscopic remission.(12 weeks)
- Biochemical remission at 12 weeks defined as fecal calprotectin less than 150 μg/g.(12 weeks)
- 7. Adverse events at 12 weeks in both groups: nausea, drowsiness, anti-cholinergic side effects (constipation, xerostomia, blurred vision, and urinary retention), and ECG abnormalities (QTc prolongation)(12 weeks)
研究者
Vineet Ahuja
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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