Safety and Tolerability of Seroguard Use
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03640559 |
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Recruitment Status :
Completed
First Posted : August 21, 2018
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adhesion | Drug: Seroguard Drug: Placebos | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | laparoscopic cholecystectomy |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | The present study was planned as double-blind, placebo-controlled study. With the aim of maximum objectification of end point, neither Medical Investigator, nor patients had access to the code of healthcare institution. The test drug or the placebo were received by the sites as ready for use and blinded vials, 200 mL each. Each vial had individual number and identification of contents ("Drug A" or "Drug B"). Conformity of identification of Seroguard or the placebo was not disclosed to the sites. Before surgery, the Medical Investigator prepared required number of vials according to identification of the drug on the vial and identification of the group in randomization envelope of patient. Individual number of each vial administered to a patient was recorded in documentation of site. |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | May 19, 2015 |
| Actual Primary Completion Date : | October 4, 2015 |
| Actual Study Completion Date : | October 4, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
the group were having the administration of Placebo (saline 2.4 mL/kg IP)
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Drug: Placebos |
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Experimental: Seroguard
the group were having the administration of Seroguard 0.41 g/L solution, 2.4 mL/kg IP
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Drug: Seroguard |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients.
- Age from 18 to 75 years, inclusive.
- Signed informed consent form.
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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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640559
| Study Director: | Mikhail Shurygin, PhD | Pharmasyntez |
| Responsible Party: | Pharmasyntez |
| ClinicalTrials.gov Identifier: | NCT03640559 |
| Other Study ID Numbers: |
SG -1/1014 |
| First Posted: | August 21, 2018 Key Record Dates |
| Results First Posted: | May 3, 2019 |
| Last Update Posted: | May 3, 2019 |
| Last Verified: | August 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
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