Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study of Safety and Tolerability of Seroguard, Solution (JSC Pharmasyntez, Russia) in Patients Undergoing a Planned Laparoscopic Cholecystectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile
详细描述
The present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. After successful completion of screening procedures, patient underwent a planned laparoscopy. Randomization of patients into groups was performed on the day of surgery using envelops. The test drug or the placebo were used at the completion stage of surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. Discharge of patient from the hospital with no contraindications was possible on Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis. Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The present study was planned as double-blind, placebo-controlled study. With the aim of maximum objectification of end point, neither Medical Investigator, nor patients had access to the code of healthcare institution.
The test drug or the placebo were received by the sites as ready for use and blinded vials, 200 mL each. Each vial had individual number and identification of contents ("Drug A" or "Drug B"). Conformity of identification of Seroguard or the placebo was not disclosed to the sites.
Before surgery, the Medical Investigator prepared required number of vials according to identification of the drug on the vial and identification of the group in randomization envelope of patient. Individual number of each vial administered to a patient was recorded in documentation of site.
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
- •Male and female patients.
- •Age from 18 to 75 years, inclusive.
- •Signed informed consent form.
- •One of the following diagnoses as per International classification of diseases -10:
- •K80.1 Calculus of gallbladder with other cholecystitis 4.
- •K80.2 Calculus of gallbladder without cholecystitis
- •Indications for planned laparoscopic cholecystectomy.
排除标准
- •Recall of informed consent by patient.
- •Non-compliance with the rules of participating in the study by patient.
- •Getting pregnant.
- •Required conversion during surgery.
- •Required repeated surgery.
- •Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient.
- •Another reasons appeared during the study and interfering conduction of the study as per the protocol.
研究组 & 干预措施
Placebo
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
干预措施: Placebos (Drug)
Seroguard
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
干预措施: Seroguard (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: 28 days
Evaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter: * Vital signs (body temperature, BP, HR, RR) * Laboratory investigations: * Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine * Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR * Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT) * Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts * 12-channel ECG data - heart rate \[HR\], PR, QRS, QT intervals and calculated QTc interval * USG data * Incidence of adverse reactions * Incidence of serious adverse reactions
次要结局
未报告次要终点