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Efficacy and Dose Ranging Study of Seroguard

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ClinicalTrials.gov Identifier: NCT03660787
Recruitment Status : Completed
First Posted : September 7, 2018
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
Cromos Pharma, LLC
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: Placebo
Enrollment 114
Recruitment Details  
Pre-assignment Details 114 is the number of enrolled and screened participants according to the protocol, but during the screening process some people were withdrawn from the study before randomization because some of them did not meet the inclusion criteria and some withdrew the informed consent form themselves. So, the number of randomized participants is 104.
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Period Title: Overall Study
Started 26 26 26 26
Completed 25 25 25 26
Not Completed 1 1 1 0
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg Total
Hide Arm/Group Description

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Total of all reporting groups
Overall Number of Baseline Participants 26 26 26 26 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 26 participants 26 participants 104 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
104
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 26 participants 26 participants 26 participants 104 participants
31.0  (6.2) 31.6  (5.3) 31.6  (5.4) 31.6  (5.4) 31.5  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 26 participants 26 participants 104 participants
Female
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian race Number Analyzed 26 participants 26 participants 26 participants 26 participants 104 participants
26
 100.0%
26
 100.0%
26
 100.0%
26
 100.0%
104
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 26 participants 26 participants 26 participants 26 participants 104 participants
26 26 26 26 26
1.Primary Outcome
Title Number of Participants With Reduction of Adhesions Number by 3 or More
Hide Description The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI
Time Frame 30±4 days after surgical intervention
Hide Outcome Measure Data
Hide Analysis Population Description
7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 24 25 23 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.2%
1
   4.0%
10
  43.5%
10
  40.0%
2.Secondary Outcome
Title Change in Thickness of Pelvic Adhesions
Hide Description The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 24 25 23 25
Median (Full Range)
Unit of Measure: score on a scale
0
(0 to 2)
0
(0 to 1)
0
(0 to 2)
0
(0 to 2)
3.Secondary Outcome
Title Number of Participants With Detection of Pelvic Organs Limited Mobility
Hide Description The frequency was estimated based on transvaginal ultrasound results
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
4 4 0 2
4.Secondary Outcome
Title Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
Hide Description The frequency was estimated based on transvaginal ultrasound results
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
3 2 1 3
5.Secondary Outcome
Title Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
Hide Description Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
-17 -17 -21 -21
6.Secondary Outcome
Title Change Number of Participants in Detecting Hyperechoic Linear Lesions
Hide Description Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Number
Unit of Measure: participants
-17 -16 -19 -18
7.Secondary Outcome
Title Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
Hide Description No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown
Time Frame 30±4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description:

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

Overall Number of Participants Analyzed 26 26 26 26
Measure Type: Count of Participants
Unit of Measure: Participants
19
  73.1%
19
  73.1%
23
  88.5%
20
  76.9%
Time Frame 30+-4 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Hide Arm/Group Description

each subject received the placebo at the dose of 1.5 mL/kg of body weight;

Placebo: Saline

each subject received the placebo at the dose of 2.4 mL/kg of body weight;

Placebo: Saline

each subject received the test drug at the dose of 1.5 mL/kg of body weight;

Seroguard: Seroguard 0.41 g/L solution

each subject received the test drug at the dose of 2.4 mL/kg of body weight.

Seroguard: Seroguard 0.41 g/L solution

All-Cause Mortality
Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/26 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo, 1.5 mL/kg Placebo, 2.4 mL/kg Seroguard, 1.5 mL/kg Seroguard, 2.4 mL/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      2/25 (8.00%)      1/25 (4.00%)      0/26 (0.00%)    
Blood and lymphatic system disorders         
Anaemia   1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0 0/26 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower   1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0 0/26 (0.00%)  0
Infections and infestations         
Respiratory tract infection viral   0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0 0/26 (0.00%)  0
Reproductive system and breast disorders         
Dysmenorrhoea   0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0 0/26 (0.00%)  0
Polymenorrhoea   1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus   0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1 0/26 (0.00%)  0
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 1150
EMail: m.shurygin@pharmasyntez.com
Publications:
Schwartz L, Diamond M. Formation, Reduction, and Treatment of Adhesive Disease. Seminars in Reproductive Medicine. 1991; 9(02): p. 89-99.
U.S. Food and Drug Administration. U.S. Food and Drug Administration. [Online]. Northborough; 2006 [cited 2015 Dec 22. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4217b1_01_Executive%20Summary.pdf.
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Non-Inferiority Clinical Trials.; 2010 [cited 2015 Dec. Available from: http://www.fda.gov/downloads/Drugs/./Guidances/UCM202140.pdf.
Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed.: Chapman&Hall / CRC Biostatistics Series; 2008.
Julious SA. Sample Sizes for Clinical Trials: CRC Press/Taylor & Francis; 2010.
Layout table for additonal information
Responsible Party: Pharmasyntez
ClinicalTrials.gov Identifier: NCT03660787     History of Changes
Other Study ID Numbers: SG-2/1215
First Submitted: August 31, 2018
First Posted: September 7, 2018
Results First Submitted: October 31, 2018
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019