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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Adhesion
Interventions Drug: Seroguard
Drug: Placebos
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Seroguard
Hide Arm/Group Description

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

Placebos

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

Seroguard

Period Title: Overall Study
Started 25 25
Completed 23 24
Not Completed 2 1
Reason Not Completed
Physician Decision             1             1
Withdrawal by Subject             1             0
Arm/Group Title Placebo Seroguard Total
Hide Arm/Group Description

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

Placebos

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

Seroguard

Total of all reporting groups
Overall Number of Baseline Participants 23 24 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  82.6%
20
  83.3%
39
  83.0%
>=65 years
4
  17.4%
4
  16.7%
8
  17.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 24 participants 47 participants
49.3
(22 to 68)
51.5
(22 to 66)
50.4
(22 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 24 participants 47 participants
Female
20
  87.0%
19
  79.2%
39
  83.0%
Male
3
  13.0%
5
  20.8%
8
  17.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 23 participants 24 participants 47 participants
23 24 47
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Seroguard
Hide Arm/Group Description:

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

Placebos

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

Seroguard

Overall Number of Participants Analyzed 23 24
Measure Type: Count of Participants
Unit of Measure: Participants
16
  69.6%
17
  70.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Seroguard
Hide Arm/Group Description

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

Placebos

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

Seroguard

All-Cause Mortality
Placebo Seroguard
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Seroguard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/23 (4.35%)      2/24 (8.33%)    
Cardiac disorders     
Increased blood pressure up to 220/100 mm   0/23 (0.00%)  0 1/24 (4.17%)  1
Injury, poisoning and procedural complications     
Leukocytosis   0/23 (0.00%)  0 1/24 (4.17%)  1
Pregnancy, puerperium and perinatal conditions     
Misbirth   1/23 (4.35%)  1 0/24 (0.00%)  0
Surgical and medical procedures     
pains in the right supraclavicular area   0/23 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Seroguard
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/23 (69.57%)      17/24 (70.83%)    
Cardiac disorders     
Arterial hypertension   1/23 (4.35%)  1 3/24 (12.50%)  7
Hypertensive crisis   0/23 (0.00%)  0 2/24 (8.33%)  2
Palpitation   0/23 (0.00%)  0 1/24 (4.17%)  2
Gastrointestinal disorders     
Epigastric pain   5/23 (21.74%)  7 0/24 (0.00%)  0
Abdominal pain   1/23 (4.35%)  3 1/24 (4.17%)  3
Constipation   3/23 (13.04%)  6 2/24 (8.33%)  3
Eructation   0/23 (0.00%)  0 1/24 (4.17%)  2
Cholemesis   2/23 (8.70%)  2 1/24 (4.17%)  1
Nausea   2/23 (8.70%)  3 3/24 (12.50%)  3
Heaviness in epigastrium   3/23 (13.04%)  6 2/24 (8.33%)  2
General disorders     
Headache   6/23 (26.09%)  9 5/24 (20.83%)  16
Pain in lower extremities   1/23 (4.35%)  1 2/24 (8.33%)  2
Dizziness   1/23 (4.35%)  1 3/24 (12.50%)  4
Toothache   0/23 (0.00%)  0 1/24 (4.17%)  2
Burning sensation   0/23 (0.00%)  0 3/24 (12.50%)  8
Weakness   1/23 (4.35%)  2 3/24 (12.50%)  5
Hepatobiliary disorders     
Pain in the right hypochondrium   7/23 (30.43%)  10 3/24 (12.50%)  9
Infections and infestations     
Sore throat   0/23 (0.00%)  0 3/24 (12.50%)  3
Nervous system disorders     
Back pain   0/23 (0.00%)  0 1/24 (4.17%)  2
Renal and urinary disorders     
Kidney pain   1/23 (4.35%)  2 0/24 (0.00%)  0
Surgical and medical procedures     
Hyperthermia   11/23 (47.83%)  24 12/24 (50.00%)  18
Pain in right side of chest   2/23 (8.70%)  2 0/24 (0.00%)  0
Pain in postoperative wound   3/23 (13.04%)  3 0/24 (0.00%)  0
Pain in the right infraclavicular region   3/23 (13.04%)  3 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mikhail Shurygin
Organization: Pharmasyntez
Phone: +7 3952 550 355 ext 189
EMail: m.shurygin@pharmasyntez.com
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.
Layout table for additonal information
Responsible Party: Pharmasyntez
ClinicalTrials.gov Identifier: NCT03640559     History of Changes
Other Study ID Numbers: SG -1/1014
First Submitted: August 16, 2018
First Posted: August 21, 2018
Results First Submitted: August 24, 2018
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019