Safety and Tolerability of Seroguard Use

NCT03640559 | Completed Phase 1 Results

• 1 other identifier: SG -1/1014
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Adhesion

Keywords

Adhesion; Safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

the group were having the administration of Placebo (saline 2.4 mL/kg IP)

Drug: Placebos

Seroguard

EXPERIMENTAL

the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP

Drug: Seroguard

Interventions

Seroguard DRUG

Seroguard

Placebos DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 4.2. K80.2 Calculus of gallbladder without cholecystitis
• Indications for planned laparoscopic cholecystectomy.

You may not qualify if:

• 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.
• Another reasons appeared during the study and interfering conduction of the study as per the protocol.

Sponsors & Collaborators

• Pharmasyntez: lead
• Sciencefiles: collaborator

Related Publications (7)

• 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)

  BACKGROUND

• The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.

  BACKGROUND

• 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).

  BACKGROUND

• Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))

  BACKGROUND

• Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.

  BACKGROUND

• Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.

  BACKGROUND

• Stata Statistical Software: Release 13. College Station T:SL, 2.

  BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mikhail Shurygin
• Organization: Pharmasyntez

m.shurygin@pharmasyntez.com

+7 3952 550 355

Study Officials

• Mikhail Shurygin, PhD

  Pharmasyntez

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: laparoscopic cholecystectomy

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: May 19, 2015
• Primary Completion: October 4, 2015
• Study Completion: October 4, 2015
• Last Updated: May 3, 2019
• Results First Posted: May 3, 2019

Record last verified: 2018-08