Efficacy and Dose Ranging Study of Seroguard

June 17, 2019 updated by: Pharmasyntez

Phase II Multi-center Randomized Double-blind Placebo-controlled Efficacy and Dose Ranging Trial of the Drug Product Seroguard, Solution (JSC Pharmasyntez, Russia) Used for the Prevention of Pelvic Adhesions

This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In order to evaluate efficacy and safety of Seroguard, solution for IP administration, a study design meeting the set objectives was selected: prospective, multi-center, double-blind, randomized, parallel group, placebo-controlled study.

Given the fact that comparison with placebo is considered the best way to prove efficacy and safety of a drug and that currently there are no drugs with a similar mechanism of action at the pharmaceutical product market, a placebo-controlled, parallel group study design was selected.

A randomized, parallel group study design was chosen in order to ensure minimization of a selection bias.

Subjects were randomized into four groups (two groups of the test drug and two placebo groups corresponding to the two doses) to enable a comparison of Seroguard administration at two doses.

A double-blind study design was selected in order to ensure minimization of an outcome evaluation bias.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Krasnoyarsk Krai
      • Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660022
        • Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"
      • Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660074
        • State Educational Government-Financed Institution of Higher Professional Education "Krasnoyarsk State Medical University named after Prof. V.F. Voino-Yasenetsky" of the Ministry of Healthcare of the Russian Federation at the clinical site Publicly Funded
    • Moscow Region
      • Moscow, Moscow Region, Russian Federation, 115516
        • State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"
      • Moscow, Moscow Region, Russian Federation, 117997
        • Federal State Institution "V.I. Kulakov Research Center for Obstetrics, Gynecology, and Perinatology" of the Ministry of Healthcare and Social Development of the Russian Federation.
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420012
        • State Educational Government-Financed Institution of Higher Professional Education "Kazan State Medical University" of the Ministry of Health of the Russian at the clinical site of Kazan Maternity Hospital No. 3 named after V.S. Gruzdev
    • The Bryansk Region
      • Bryansk, The Bryansk Region, Russian Federation, 241035
        • State Funded Health Care Institution "Bryansk Municipal Hospital No 1
    • The Kemerovo Region
      • Kemerovo, The Kemerovo Region, Russian Federation, 650000
        • Federal State Educational Government-Financed Institution of Higher Education "Kemerovo State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Kemerovo Oblast Publicly Funded Healthcare Institution "L.A.
    • The Leningrad Region
      • Saint Petersburg, The Leningrad Region, Russian Federation, 194291
        • Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".
      • Saint Petersburg, The Leningrad Region, Russian Federation, 199034
        • Federal State Funded Scientific Institution "Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott" of the Ministry of Healthcare of the Russian Federation
    • The Moscow Region
      • Moscow, The Moscow Region, Russian Federation, 101000
        • Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"
      • Moscow, The Moscow Region, Russian Federation, 119415
        • State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"
    • The Rostov Region
      • Rostov-on-Don, The Rostov Region, Russian Federation, 344013
        • State Educational Government-Financed Institution of Higher Professional Education "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of Obstetrics and Pediatrics Research Institute
    • The Ryazan Region
      • Ryazan', The Ryazan Region, Russian Federation
        • Federal State Educational Government-Financed Institution of Higher Education "I.P. Pavlov Ryazan State Medical University" of the Ministry of Healthcare of the Russian Federation at the clinical site of State Funded Healthcare Institution "Municipal Clin
    • The Sverdlovsk Region
      • Yekaterinburg, The Sverdlovsk Region, Russian Federation, 620028
        • Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female patients aged from 18 to 45 years with the confirmed diagnosis of pelvic adhesions having indications for surgery (laparoscopic adhesiolysis).
  2. Voluntarily and personally signed and dated Form of Informed Consent.
  3. Female patients with pelvic adhesions confirmed by gynecological and ultrasound examination.

Exclusion Criteria:

  1. Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
  2. Body mass index of 30.0 kg/m2 and more;
  3. Known hypersensitivity to the test drug components (Seroguard);
  4. Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
  5. Refusal to use effective contraception methods throughout the study;
  6. Positive HIV, RW, HBV or HCV test result;
  7. Alcohol abuse, drug addiction, and toxicomania (except smoking);
  8. American Society of Anesthesiologists physical status category III and more (ASA);
  9. Purulent process in the abdominal cavity;
  10. Disseminated endometriosis;
  11. WBC count more than 10*109/L at the complete blood count;
  12. Need of using any drugs during the surgery other than 0.02% chlorhexidine aqueous solution throughout the surgery, as well as the test drug or the placebo (0.9% sodium chloride) administered intraperitoneally in the end of surgery.
  13. Concomitant diseases that may require conversion of the surgical intervention by other indications;
  14. Type I or II diabetes mellitus;
  15. Deep vein thrombosis and/or PATE at the screening or in the medical history;
  16. Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);
  17. Liver disorders defined as more than 2-fold rise of the upper limit of normal of one of the following enzymes: ALT, AST, GGTP, AP, or more than 2-fold total bilirubin increase;
  18. Myocardial infarction within 6 months before screening;
  19. Any concomitant diseases accompanied by heart failure;
  20. Clinically significant ECG changes (as to the investigator's opinion);
  21. Any concomitant diseases accompanied by respiratory failure;
  22. Any oncological disease within 3 years before enrollment into the study;
  23. Systemic inflammatory diseases;
  24. Diseases associated with chronic hemorrhages;
  25. Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);
  26. Any other disease that, in the investigator's opinion, may affect study results or present an additional threat to well-being of a patient after administration of the study drug;
  27. Use of anticoagulants, antiaggregants (except for acetylsalicylic acid at the dose of less than 325 mg/day) at the moment of inclusion into the study or planning to do so during the study;
  28. Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;
  29. Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.
  30. Participation in any other clinical trial within 30 days before screening;
  31. Contraindications to MRI (presence of implants or implanted electronic devices);
  32. Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo, 1.5 mL/kg
each subject received the placebo at the dose of 1.5 mL/kg of body weight;
Drug: Placebo
Saline
PLACEBO_COMPARATOR: Placebo, 2.4 mL/kg
each subject received the placebo at the dose of 2.4 mL/kg of body weight;
Drug: Placebo
Saline
EXPERIMENTAL: Seroguard, 1.5 mL/kg
each subject received the test drug at the dose of 1.5 mL/kg of body weight;
Drug: Seroguard
Seroguard 0.41 g/L solution
EXPERIMENTAL: Seroguard, 2.4 mL/kg
each subject received the test drug at the dose of 2.4 mL/kg of body weight.
Drug: Seroguard
Seroguard 0.41 g/L solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Reduction of Adhesions Number by 3 or More
Time Frame: 30±4 days after surgical intervention
The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI
30±4 days after surgical intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Thickness of Pelvic Adhesions
Time Frame: 30±4 days after surgery
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.
30±4 days after surgery
Number of Participants With Detection of Pelvic Organs Limited Mobility
Time Frame: 30±4 days after surgery
The frequency was estimated based on transvaginal ultrasound results
30±4 days after surgery
Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
Time Frame: 30±4 days after surgery
The frequency was estimated based on transvaginal ultrasound results
30±4 days after surgery
Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
Time Frame: 30±4 days after surgery
Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline
30±4 days after surgery
Change Number of Participants in Detecting Hyperechoic Linear Lesions
Time Frame: 30±4 days after surgery
Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)
30±4 days after surgery
Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
Time Frame: 30±4 days after surgery
No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown
30±4 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmasyntez

Collaborators

Cromos Pharma LLC

Investigators

  • Study Chair: Mikhail Shurygin, PhD,D.M.Sc., Pharmasyntez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2017

Primary Completion (ACTUAL)

January 23, 2018

Study Completion (ACTUAL)

January 23, 2018

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (ACTUAL)

September 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG-2/1215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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