Efficacy and Dose Ranging Study of Seroguard

NCT03660787 | Completed Phase 2 Results

• 1 other identifier: SG-2/1215
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 14

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.

Conditions

Adhesion

Keywords

Adhesion; Efficacy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Reduction of Adhesions Number by 3 or More

  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 Outcomes (6)

• Change in Thickness of Pelvic Adhesions

  30±4 days after surgery

• Number of Participants With Detection of Pelvic Organs Limited Mobility

  30±4 days after surgery

• Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery

  30±4 days after surgery

• Change in Number of Participants in Detecting Pelvic Organs Limited Mobility

  30±4 days after surgery

• Change Number of Participants in Detecting Hyperechoic Linear Lesions

  30±4 days after surgery

Study Arms (4)

Placebo, 1.5 mL/kg

PLACEBO COMPARATOR

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

Drug: Placebo

Placebo, 2.4 mL/kg

PLACEBO COMPARATOR

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

Drug: Placebo

Seroguard, 1.5 mL/kg

EXPERIMENTAL

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

Drug: Seroguard

Seroguard, 2.4 mL/kg

EXPERIMENTAL

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

Drug: Seroguard

Interventions

Seroguard DRUG

Seroguard 0.41 g/L solution

Seroguard, 1.5 mL/kg; Seroguard, 2.4 mL/kg

Placebo DRUG

Saline

Placebo, 1.5 mL/kg; Placebo, 2.4 mL/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Female patients having contraindications to surgical treatment (including acute or exacerbated chronical adnexal inflammation);
• Body mass index of 30.0 kg/m2 and more;
• Known hypersensitivity to the test drug components (Seroguard);
• Pregnancy, breastfeeding or planning a pregnancy during the clinical trial;
• Refusal to use effective contraception methods throughout the study;
• Positive HIV, RW, HBV or HCV test result;
• Alcohol abuse, drug addiction, and toxicomania (except smoking);
• American Society of Anesthesiologists physical status category III and more (ASA);
• Purulent process in the abdominal cavity;
• Disseminated endometriosis;
• WBC count more than 10\*109/L at the complete blood count;
• 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.
• Concomitant diseases that may require conversion of the surgical intervention by other indications;
• Type I or II diabetes mellitus;
• Deep vein thrombosis and/or PATE at the screening or in the medical history;

Sponsors & Collaborators

• Pharmasyntez: lead
• Cromos Pharma LLC: collaborator

Study Sites (14)

Krai Government-Owned State Funded Healthcare Institution "Krai Clinical Hospital"

Krasnoyarsk, Krasnoyarsk Krai, 660022, Russia

Location

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, 660074, Russia

Location

State Funded Healthcare Institution of Moscow of City Health Department "V.M. Buyanov Municipal Clinical Hospital"

Moscow, Moscow Oblast, 115516, Russia

Location

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 Oblast, 117997, Russia

Location

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', Tatarstan Republic, 420012, Russia

Location

State Funded Health Care Institution "Bryansk Municipal Hospital No 1

Bryansk, The Bryansk Region, 241035, Russia

Location

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, 650000, Russia

Location

Federal State Funded Healthcare Institution "L.G. Sokolov Federal Biomedical Agency Clinical Hospital No 122".

Saint Petersburg, The Leningrad Region, 194291, Russia

Location

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, 199034, Russia

Location

Moscow Oblast State Funded Healthcare Institution "Moscow Oblast Research Institute of Obstetrics and Gynecology"

Moscow, The Moscow Region, 101000, Russia

Location

State Funded Healthcare Institution of Moscow of City Health Department "Moscow Municipal Clinical Hospital No 31"

Moscow, The Moscow Region, 119415, Russia

Location

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, 344013, Russia

Location

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, Russia

Location

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, 620028, Russia

Location

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MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mikhail Shurygin
• Organization: Pharmasyntez

m.shurygin@pharmasyntez.com

+7 3952 550 355

Study Officials

• Mikhail Shurygin, PhD,D.M.Sc.

  Pharmasyntez

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 7, 2018
• Study Start: May 4, 2017
• Primary Completion: January 23, 2018
• Study Completion: January 23, 2018
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-06

Locations

RU (14)