search
Back to results

Safety and Tolerability of Seroguard Use

Primary Purpose

Adhesion

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Seroguard
Placebos
Sponsored by
Pharmasyntez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adhesion focused on measuring Adhesion, Safety

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Seroguard

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    January 31, 2019
    Sponsor
    Pharmasyntez
    Collaborators
    Sciencefiles
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03640559
    Brief Title
    Safety and Tolerability of Seroguard Use
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 19, 2015 (Actual)
    Primary Completion Date
    October 4, 2015 (Actual)
    Study Completion Date
    October 4, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pharmasyntez
    Collaborators
    Sciencefiles

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesion
    Keywords
    Adhesion, Safety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    laparoscopic cholecystectomy
    Masking
    ParticipantInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    the group were having the administration of Placebo (saline 2.4 mL/kg IP)
    Arm Title
    Seroguard
    Arm Type
    Experimental
    Arm Description
    the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
    Intervention Type
    Drug
    Intervention Name(s)
    Seroguard
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events (AEs)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mikhail Shurygin, PhD
    Organizational Affiliation
    Pharmasyntez
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    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)
    Results Reference
    background
    Citation
    The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
    Results Reference
    background
    Citation
    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).
    Results Reference
    background
    Citation
    Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
    Results Reference
    background
    Citation
    Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
    Results Reference
    background
    Citation
    Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
    Results Reference
    background
    Citation
    Stata Statistical Software: Release 13. College Station T:SL, 2.
    Results Reference
    background

    Learn more about this trial

    Safety and Tolerability of Seroguard Use

    We'll reach out to this number within 24 hrs