Clinical trial NCT03640559: Safety and Tolerability of Seroguard Use
Official title: Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study of Safety and Tolerability of Seroguard, Solution (JSC Pharmasyntez, Russia) in Patients Undergoing a Planned Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adhesion
Keywords: Adhesion
Safety
Lead sponsor: Pharmasyntez
Sponsor class: INDUSTRY
Collaborators: name: Sciencefiles
First posted: 2018-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: laparoscopic cholecystectomy
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pharmasyntez
name: Mikhail Shurygin, PhD
role: STUDY_DIRECTOR
References:
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citation: The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
citation: GOST R 52379-2005 "National standard of the Russian Federation "Good Clinical Practice" (approved by the Order of the Federal Agency for Technical Regulation and Metrology dated 27th of September, 2005 No 232-ст).
citation: Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
citation: Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
citation: Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
citation: Stata Statistical Software: Release 13. College Station T:SL, 2.