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Safety and Tolerability of Seroguard Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640559
Recruitment Status : Completed
First Posted : August 21, 2018
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Sciencefiles
Information provided by (Responsible Party):
Pharmasyntez

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

Condition or disease Intervention/treatment Phase
Adhesion Drug: Seroguard Drug: Placebos Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: laparoscopic cholecystectomy
Masking: Double (Participant, Investigator)
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.

Primary Purpose: Prevention
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
Actual Study Start Date : May 19, 2015
Actual Primary Completion Date : October 4, 2015
Actual Study Completion Date : October 4, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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



Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640559


Sponsors and Collaborators
Pharmasyntez
Sciencefiles
Investigators
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Study Director: Mikhail Shurygin, PhD Pharmasyntez

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.

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Responsible Party: Pharmasyntez
ClinicalTrials.gov Identifier: NCT03640559     History of Changes
Other Study ID Numbers: SG -1/1014
First Posted: August 21, 2018    Key Record Dates
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Pharmasyntez:
Adhesion
Safety
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes