Safety and Tolerability of Seroguard Use

Adhesion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640559
• Other study ID #: SG -1/1014
• Status: Completed
• Phase: Phase 1
• Start date: May 19, 2015
• Est. completion date: October 4, 2015

Study information

• Verified date: August 2018
• Source: Pharmasyntez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 4, 2015
• Est. primary completion date: October 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesion
• Tissue Adhesions

Intervention

Drug:
• Seroguard

• Placebos

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pharmasyntez	Sciencefiles

References & Publications (7)

Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.

Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))

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-??).

Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.

Stata Statistical Software: Release 13. College Station T:SL, 2.

The Federal Law dated 12.04.2010 ?61-?? "On drug circulation" (as amended Federal Laws dated 27.07.2010 N 192-??, dated 11.10.2010 N 271-??, dated 29.11.2010 N 313-??, dated 06.12.2011 N 409-??, dated 25.06.2012 N 93-??, dated 25.12.2012 N 262-??, dated 02.07.2013 N 185-??, dated 25.11.2013 N 317-??, dated 12.03.2014 N 33-??, dated 22.10.2014 N 313-??)

The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	Evaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter: Vital signs (body temperature, BP, HR, RR); Laboratory investigations: Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine; Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR; Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT); Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts; 12-channel ECG data - heart rate [HR], PR, QRS, QT intervals and calculated QTc interval; USG data; Incidence of adverse reactions; Incidence of serious adverse reactions	28 days