SG -1/1014

About this trial

Last updated 6 years ago

Study ID

SG -1/1014

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18 to 75 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 10 years ago

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

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.

Safety and Tolerability of Seroguard Use