Safety and Tolerability of Seroguard Use

Phase 1

Completed

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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:

4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of gallbladder without cholecystitis
Indications for planned laparoscopic cholecystectomy.

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	the group were having the administration of Placebo (saline 2.4 mL/kg IP)
Seroguard	Seroguard	the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	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