Safety and Tolerability of Seroguard Use

• Status: Completed
• Trial end date: 2015-10-04
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmasyntez
• Collaborator: Sciencefiles

Criteria

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.