AdhesionPhase 1NCT03640559
Safety and Tolerability of Seroguard Use
A Phase 1 study testing Seroguard in people with Adhesion, run by Pharmasyntez.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adhesion
- What is being tested?
- Seroguard
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2015to 4 Oct 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients.
- Age from 18 to 75 years, inclusive.
- Signed informed consent form.
- 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
- Indications for planned laparoscopic cholecystectomy.
Who cannot join
- Recall of informed consent by patient.
- Non-compliance with the rules of participating in the study by patient.
- Getting pregnant.
- Required conversion during surgery.
- Required repeated surgery.
- Development of diseases described in non-inclusion criteria, required use of drugs not provided by the protocol in patient.
- Another reasons appeared during the study and interfering conduction of the study as per the protocol.
About this study
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
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
Read the 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.
- Conditions
- Adhesion
- Being tested
- Seroguard, Placebos
- Keywords
- Adhesion, Safety
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeroguardDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | the group were having the administration of Placebo (saline 2.4 mL/kg IP) Receives: Drug: Placebos |
| Seroguard | Experimental | the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP Receives: Drug: Seroguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start19 May 2015
- Primary completion4 Oct 2015
- Study completion4 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- laparoscopic cholecystectomy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasyntez
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sciencefiles
- Responsible party
- Sponsor
- Investigators
- Mikhail Shurygin, PhD, Study director, Pharmasyntez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640559
- Sponsor's protocol ID
- SG -1/1014
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
Publications
The Federal Law dated 12.04.2010 №61-ФЗ "On drug circulation" (as amended Federal Laws dated 27.07.2010 N 192-ФЗ, dated 11.10.2010 N 271-ФЗ, dated 29.11.2010 N 313-ФЗ, dated 06.12.2011 N 409-ФЗ, dated 25.06.2012 N 93-ФЗ, dated 25.12.2012 N 262-ФЗ, dated 02.07.2013 N 185-ФЗ, dated 25.11.2013 N 317-ФЗ, dated 12.03.2014 N 33-ФЗ, dated 22.10.2014 N 313-ФЗ)
The Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
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).
Declaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
Guideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
Bonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
Stata Statistical Software: Release 13. College Station T:SL, 2.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03640559
- Acronym / sponsor ID
- SG -1/1014
- Conditions
- Adhesion
- Keywords
- Adhesion, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- PharmasyntezIndustry (pharma, biotech, devices)
- Collaborators
- Sciencefiles
- Study start
- 19 May 2015 (actual)
- Primary completion
- 4 Oct 2015 (actual)
- Study completion
- 4 Oct 2015 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 3 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- laparoscopic cholecystectomy
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebosthe group were having the administration of Placebo (saline 2.4 mL/kg IP) |
| Seroguard | Experimental | Drug: Seroguardthe group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients.
- Age from 18 to 75 years, inclusive.
- Signed informed consent form.
- 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
Key exclusion criteria (7 listed)
- Recall of informed consent by patient.
- Non-compliance with the rules of participating in the study by patient.
- Getting pregnant.
- Required conversion during surgery.
- Required repeated surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seroguard | Drug | Seroguard |
| Placebos | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: 28 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundThe Federal Law dated 12.04.2010 №61-ФЗ "On drug circulation" (as amended Federal Laws dated 27.07.2010 N 192-ФЗ, dated 11.10.2010 N 271-ФЗ, dated 29.11.2010 N 313-ФЗ, dated 06.12.2011 N 409-ФЗ, dated 25.06.2012 N 93-ФЗ, dated 25.12.2012 N 262-ФЗ, dated 02.07.2013 N 185-ФЗ, dated 25.11.2013 N 317-ФЗ, dated 12.03.2014 N 33-ФЗ, dated 22.10.2014 N 313-ФЗ)
- BackgroundThe Order of the Ministry of Health, the Russian Federation, No 266 dated 19.06.2003.
- BackgroundGOST 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).
- BackgroundDeclaration of Helsinki, World Medical Association (as revised, approved at 64th General Assembly, Fortaleza (Brazil, 2013))
- BackgroundGuideline on inspection of medicinal drugs. Volume I. Grif and K, 2013. - 328 p.
- BackgroundBonferroni, C. E. (1936). Teoria statistica delle classi e calcolo delle probabilità, Pubblicazioni del R Istituto Superiore di Scienze Economiche e Commerciali di Firenze.
- BackgroundStata Statistical Software: Release 13. College Station T:SL, 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Shurygin, PhD study director
Pharmasyntez
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seroguard in people with Adhesion, run by Pharmasyntez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640559, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.