CTRI/2010/091/001096已完成3 期
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects with mild or severe acute pancreatitis.
Bharat Serums and Vaccines Ltd14 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年7月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Serum CRP Levels
研究概览
简要总结
The study is a randomised, placebo controlled, double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in treatment of Mild or Severe Acute Pancreatitis. Ulinastatin (100000IU)/ Placebo will be given b.d. for 3 days for mild acute pancreatitis and 5 days for severe acute pancreatitis . The primary outcome measure is Number of days for Serum CRP levels to normalize and secondary outcome measures are Mortality, Average length of hospital stay (days) till discharge in survivors and Complications including new onset organ failure. This study will be conducted in twelve centers in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •Age >18years <70years (both inclusive) II.
- •Any two of the following three should be present:
- •Abdominal pain characteristic of acute pancreatitis
- •Serum amylase and/or lipase ≥ 3 times the upper limit of normal
- •Characteristic findings of acute pancreatitis on USG, contrast-enhanced CT or MRI.
排除标准
- •Pregnancy or breast-feeding
- •Evidence of chronic pancreatitis on imaging (calcification, ductal irregularity or dilatation)
- •Subjects requiring immediate surgery
- •Moribund state in which death was perceived to be imminent ( ≤ 24 hours)
- •Participation in another investigational study within 30 days before the current study.
结局指标
主要结局
Serum CRP Levels
时间窗: Day 0,3,5,7,12,22
次要结局
- Mortality(Up to Day 22 or Discharge whichever is earlier)
- Length Of Hospital Stay (Days)In Survivors.(Up To Day 22 Or Discharge Whichever Is Earlier)
- Complications, Including New Onset Organ Failure(Up To Day 22 Or Discharge Whichever Is Earlier)
研究者
研究点 (14)
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