Clinical trial NCT03660787: Efficacy and Dose Ranging Study of Seroguard
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adhesion
Keywords: Adhesion
Efficacy
Lead sponsor: Pharmasyntez
Sponsor class: INDUSTRY
Collaborators: name: Cromos Pharma LLC
First posted: 2018-09-07
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Reduction of Adhesions Number by 3 or More
timeFrame: 30±4 days after surgical intervention
Secondary outcomes:
measure: Change in Thickness of Pelvic Adhesions
timeFrame: 30±4 days after surgery
measure: Number of Participants With Detection of Pelvic Organs Limited Mobility
timeFrame: 30±4 days after surgery
measure: Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery
timeFrame: 30±4 days after surgery
measure: Change in Number of Participants in Detecting Pelvic Organs Limited Mobility
timeFrame: 30±4 days after surgery
measure: Change Number of Participants in Detecting Hyperechoic Linear Lesions
timeFrame: 30±4 days after surgery
measure: Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery
timeFrame: 30±4 days after surgery
Other outcomes:
Locations:
city: Krasnoyarsk
country: Russian Federation
facility: Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"
state: Krasnoyarsk Krai
city: Krasnoyarsk
country: Russian Federation
facility: 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
state: Krasnoyarsk Krai
city: Moscow
country: Russian Federation
facility: State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"
state: Moscow Region
city: Moscow
country: Russian Federation
facility: 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.
state: Moscow Region
city: Kazan
country: Russian Federation
facility: 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
state: Republic Of Tatarstan
city: Bryansk
country: Russian Federation
facility: State Funded Health Care Institution "Bryansk Municipal Hospital No 1
state: The Bryansk Region
city: Kemerovo
country: Russian Federation
facility: 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.
state: The Kemerovo Region
city: Saint Petersburg
country: Russian Federation
facility: Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".
state: The Leningrad Region
city: Saint Petersburg
country: Russian Federation
facility: 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
state: The Leningrad Region
city: Moscow
country: Russian Federation
facility: Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"
state: The Moscow Region
city: Moscow
country: Russian Federation
facility: State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"
state: The Moscow Region
city: Rostov-on-Don
country: Russian Federation
facility: 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
state: The Rostov Region
city: Ryazan'
country: Russian Federation
facility: 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
state: The Ryazan Region
city: Yekaterinburg
country: Russian Federation
facility: Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation
state: The Sverdlovsk Region
Study officials:
affiliation: Pharmasyntez
name: Mikhail Shurygin, PhD,D.M.Sc.
role: STUDY_CHAIR
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