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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 14
- 主要终点
- Number of Participants With Reduction of Adhesions Number by 3 or More
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Renal impairment (glomerular filtration rate less than 60 mL/min/1.73 m2 assessed by the CKD-EPI equation);
- •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;
- •Myocardial infarction within 6 months before screening;
- •Any concomitant diseases accompanied by heart failure;
- •Clinically significant ECG changes (as to the investigator's opinion);
- •Any concomitant diseases accompanied by respiratory failure;
- •Any oncological disease within 3 years before enrollment into the study;
- •Systemic inflammatory diseases;
- •Diseases associated with chronic hemorrhages;
- •Blood diseases (anemias of any origin, hemoglobinopathies, inherited and acquired coagulopathies, hemostasis disorders, thrombocytopenias, and thrombocytopathias, any hemoblastoses);
- •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;
- •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;
- •Use of drugs with pronounced hemato-, hepato-, or nephrotoxic action, drugs of biological origin;
- •Need to administer cytostatics, systemic glucocorticosteroids, and other immunosuppressive agents during the patient's participation in the study.
- •Participation in any other clinical trial within 30 days before screening;
- •Contraindications to MRI (presence of implants or implanted electronic devices);
- •Impossibility or inability to comply with the requirements of the protocol, including for physical, psychic or social reasons, in the investigator's opinion.
研究组 & 干预措施
Placebo, 1.5 mL/kg
each subject received the placebo at the dose of 1.5 mL/kg of body weight;
干预措施: Placebo (Drug)
Placebo, 2.4 mL/kg
each subject received the placebo at the dose of 2.4 mL/kg of body weight;
干预措施: Placebo (Drug)
Seroguard, 1.5 mL/kg
each subject received the test drug at the dose of 1.5 mL/kg of body weight;
干预措施: Seroguard (Drug)
Seroguard, 2.4 mL/kg
each subject received the test drug at the dose of 2.4 mL/kg of body weight.
干预措施: Seroguard (Drug)
结局指标
主要结局
Number of Participants With Reduction of Adhesions Number by 3 or More
时间窗: 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
次要结局
- Change Number of Participants in Detecting Hyperechoic Linear Lesions(30±4 days after surgery)
- 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)
- Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery(30±4 days after surgery)