CTRI/2015/10/006252已完成2 期
A double-blind, randomized, two-arm, parallel, clinical study to evaluate efficacy, safety and tolerability of two dose strengths of tacrolimus lipid suspension for injection rectally administered in adult patients with mild to moderately active left-sided/distal ulcerative colitis including proctosigmoiditis/proctitis refractory to mesalamine treatment - NA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria with mild to moderate active disease
- •2.Subjects with a modified Ulcerative Colitis Disease Activity Index (UCDAI) score of 4-10
- •3.Rectal bleeding score of 1 or more
- •4.Mucosal appearance score of 1 point or more at baseline
排除标准
- •1.Documented history of proximal or universal ulcerative colitis
- •2.Patients who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •3.Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
- •4.Patients stool contains enteric pathogens or Clostridium difficile toxins.
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