Safety and Tolerability of Seroguard Use

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

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

Study Overview

• Status: Completed
• Conditions: Adhesion
• Intervention / Treatment: Drug: Placebos; Drug: Seroguard

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; the group were having the administration of Placebo (saline 2.4 mL/kg IP)	Drug: Placebos
EXPERIMENTAL: Seroguard; the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP	Drug: Seroguard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days

Collaborators and Investigators

• Sponsor: Pharmasyntez
• Collaborators: Sciencefiles
• Investigators: Study Director: Mikhail Shurygin, PhD, Pharmasyntez

Publications and helpful links

General Publications

• The Federal Law dated 12.04.2010 №61-ФЗ "On drug circulation" (as amended Federal Laws dated 27.07.2010 N 192-ФЗ, dated 11.10.2010 N 271-ФЗ, dated 29.11.2010 N 313-ФЗ, dated 06.12.2011 N 409-ФЗ, dated 25.06.2012 N 93-ФЗ, dated 25.12.2012 N 262-ФЗ, dated 02.07.2013 N 185-ФЗ, dated 25.11.2013 N 317-ФЗ, dated 12.03.2014 N 33-ФЗ, dated 22.10.2014 N 313-ФЗ)
• The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
• GOST R 52379-2005 "National standard of the Russian Federation "Good Clinical Practice" (approved by the Order of the Federal Agency for Technical Regulation and Metrology dated 27th of September, 2005 No 232-ст).
• Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
• Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
• Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
• Stata Statistical Software: Release 13. College Station T:SL, 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2015
• Primary Completion (ACTUAL): October 4, 2015
• Study Completion (ACTUAL): October 4, 2015

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Adhesion
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: SG -1/1014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No