Safety and Tolerability of Seroguard Use

PHARMASYNTEZ

Status and phase: Completed; Phase 1

Conditions: Adhesion

Treatments: Drug: Seroguard; Drug: Placebos

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03640559

SG -1/1014

Details and patient eligibility

About

The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez, Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that patients from the both groups had the similar safety profile

Full description

The present study was conducted as multicenter, randomized, double-blind, parallel group clinical study. After successful completion of screening procedures, patient underwent a planned laparoscopy. Randomization of patients into groups was performed on the day of surgery using envelops. The test drug or the placebo were used at the completion stage of surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion of surgery. Discharge of patient from the hospital with no contraindications was possible on Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis. Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at evaluation of safety and tolerability of using the test drug or the placebo were identical in main and control groups.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients.

2. Age from 18 to 75 years, inclusive.

3. Signed informed consent form.

4. One of the following diagnoses as per International classification of diseases -10:

   4.1. K80.1 Calculus of gallbladder with other cholecystitis 4.2. K80.2 Calculus of gallbladder without cholecystitis

5. Indications for planned laparoscopic cholecystectomy.

Exclusion criteria

1. Recall of informed consent by patient.
2. Non-compliance with the rules of participating in the study by patient.
3. Getting pregnant.
4. Required conversion during surgery.
5. Required repeated surgery.
6. Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient.
7. Another reasons appeared during the study and interfering conduction of the study as per the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

the group were having the administration of Placebo (saline 2.4 mL/kg IP)

Treatment:

Drug: Placebos

Seroguard

Experimental group

Description:

the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP

Treatment:

Drug: Seroguard