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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

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.

Condition or disease Intervention/treatment Phase
Adhesion Drug: Seroguard Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

The present study was conducted as a double blind trial. Neither a medical investigator, nor patients had access to the treatment assignment code in order to ensure the maximum objective evaluation of the primary endpoint.

Blinding was performed in such a way that disclosing a randomization code of a certain subject excluded a disclosure of the code in general (i.e. the randomization code had no indication to the treatment group). However, there were no cases of the randomization code disclosure in the study

Primary Purpose: Prevention
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
Actual Study Start Date : May 4, 2017
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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): NCT03660787


Locations
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Russian Federation
Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"
Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660022
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
Krasnoyarsk, Krasnoyarsk Krai, Russian Federation, 660074
State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"
Moscow, Moscow Region, Russian Federation, 115516
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.
Moscow, Moscow Region, Russian Federation, 117997
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
Kazan, Republic Of Tatarstan, Russian Federation, 420012
State Funded Health Care Institution "Bryansk Municipal Hospital No 1
Bryansk, The Bryansk Region, Russian Federation, 241035
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.
Kemerovo, The Kemerovo Region, Russian Federation, 650000
Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".
Saint Petersburg, The Leningrad Region, Russian Federation, 194291
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
Saint Petersburg, The Leningrad Region, Russian Federation, 199034
Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"
Moscow, The Moscow Region, Russian Federation, 101000
State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"
Moscow, The Moscow Region, Russian Federation, 119415
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
Rostov-on-Don, The Rostov Region, Russian Federation, 344013
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
Ryazan', The Ryazan Region, Russian Federation
Federal State Funded Healthcare Institution "Ural Research Institute of Maternal and Infant Care" of the Ministry of Healthcare of the Russian Federation
Yekaterinburg, The Sverdlovsk Region, Russian Federation, 620028
Sponsors and Collaborators
Pharmasyntez
Cromos Pharma, LLC
Investigators
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Study Chair: Mikhail Shurygin, PhD,D.M.Sc. Pharmasyntez
  Study Documents (Full-Text)

Documents provided by Pharmasyntez:
Study Protocol  [PDF] March 6, 2017
Statistical Analysis Plan  [PDF] April 24, 2017


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.

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Responsible Party: Pharmasyntez
ClinicalTrials.gov Identifier: NCT03660787     History of Changes
Other Study ID Numbers: SG-2/1215
First Posted: September 7, 2018    Key Record Dates
Results First Posted: June 19, 2019
Last Update Posted: June 19, 2019
Last Verified: June 2019

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