A Phase 2 , Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Using Premedication With OsrhCT and Dimethicone Emulsion During Upper Gastrointestinal Endoscopy Examination.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 336
- 试验地点
- 5
- 主要终点
- Total visibility score (TVS) evaluated by blinded endoscopists
研究概览
简要总结
Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa.
A total of 336 subjects (both male and female) are expected to be enrolled in this trial.
详细描述
This is a monocentric, double-blind, randomized study involving 336 patients indicated for diagnostic upper endoscopy. Patients were randomly assigned to one of three arms, with OsrhCT 4000U+ Dimethicone emulsion 4ml , with OsrhCT 8000U+ Dimethicone emulsion 4ml , and with placebo for OsrhCT+ Dimethicone emulsion 4ml. During the examination, each photograph was individually taken in 5 defined areas. The first 30 cases were collected to establish standards and method validation. The visibility score was given by the sum of the score 1-4 from 5 defined localities evaluated by a blinded endoscopist and subsequently by two or three blinded endoscopists. Other parameters monitored were examination time and a semiquantitative evaluation of residual gastric fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated for gastroscopy examination;
- •Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
- •Able to complete the research according to the requirements of the experimental plan;
- •Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug;
- •Aged 18-75 years (inclusive), male or female;
排除标准
- •Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination;
- •Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
- •Subjects accessed not to stand sedation anesthesia or gastroscopy examination;
- •Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
- •Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
- •Abnormal laboratory values:: alanine aminotransferase (ALT)>2 × ULN, aspartate aminotransferase (AST)>2 × ULN, serum creatinine>1.5 × ULN;
- •Female subjects who had unprotected sex within 14 days prior to screening;
- •Pregnant or breastfeeding women;
- •Subjects who have participated in any drug clinical trial and received treatment within the last 3 months;
- •Any other conditions deemed unsuitable for the study by the investigator.
研究组 & 干预措施
Recombinant Human Chymotrypsin(OsrhCT) 4000U
干预措施: Recombinant Human Chymotrypsin(OsrhCT) 4000U (Drug)
Recombinant Human Chymotrypsin(OsrhCT) 4000U
干预措施: Placebo for Recombinant Human Chymotrypsin(OsrhCT) (Drug)
Recombinant Human Chymotrypsin(OsrhCT) 4000U
干预措施: Dimethicone emulsion 4ml (Drug)
Recombinant Human Chymotrypsin(OsrhCT) 8000U
干预措施: Recombinant Human Chymotrypsin(OsrhCT) 4000U (Drug)
Recombinant Human Chymotrypsin(OsrhCT) 8000U
干预措施: Dimethicone emulsion 4ml (Drug)
Placebo for Recombinant Human Chymotrypsin(OsrhCT)
干预措施: Placebo for Recombinant Human Chymotrypsin(OsrhCT) (Drug)
Placebo for Recombinant Human Chymotrypsin(OsrhCT)
干预措施: Dimethicone emulsion 4ml (Drug)
结局指标
主要结局
Total visibility score (TVS) evaluated by blinded endoscopists
时间窗: Through study completion, an average of 3 months
"Total visibility score"counted as the sum of visibility score in lower esophagus, gastric fundus, upper gastric body, lower gastric body and gastric antrum.
次要结局
- Vsibility scores evaluated by blinded endoscopists for mucosain of 5 various anatomical parts of the stomach(Through study completion, an average of 3 months)
- The amount of water flushed for satisfactory observation of the upper gastrointestinal tract(during diagnostic upper endoscopy, up to 1 hour)
- Duration of endoscopy(during diagnostic upper endoscopy, up to 1 hour)
- Incidence of adverse events(up to 1 week)