Safety and Tolerability of Seroguard Use

Pharmasyntez50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Adhesion

Interventions

SeroguardDRUG

PlacebosDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients. 2. Age from 18 to 75 years, inclusive. 3. Signed informed consent form. 4. 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 5. Indications for planned laparoscopic cholecystectomy. Exclusion Criteria: 1. Recall of informed consent by patient. 2. Non-compliance with the rules of participating in the study by patient. 3. Getting pregnant. 4. Required conversion during surgery. 5. Required repeated surgery. 6. Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient. 7. Another reasons appeared during the study and interfering conduction of the study as per the protocol.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

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

Time frame: 28 days

Data from ClinicalTrials.gov

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