Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 10:26 PM
Study NCT ID:
NCT06365632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'increase in the sliding distance of the cecum', 'timeFrame': 'from surgery to 7 days', 'description': 'increase in the sliding distance of the cecum, determined by the results of an ultrasound examination on the 7th day after appendectomy'}], 'primaryOutcomes': [{'measure': 'Number of patients with acute phlegmonous appendicitis cured', 'timeFrame': 'from surgery to 3 weeks', 'description': 'Number of patients cured'}], 'secondaryOutcomes': [{'measure': 'absence of signs of adhesions', 'timeFrame': 'from surgery to 4 weeks', 'description': 'absence of signs of adhesions according to clinical and ultrasound studies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phlegmonous appendicitis', 'ketorolac tromethamine', 'gel', 'abdominal adhesions'], 'conditions': ['Abdominal Adhesions']}, 'descriptionModule': {'briefSummary': 'The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions.', 'detailedDescription': 'The prospective, randomized, placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis.\n\nResearch objectives:\n\n* To evaluate the immediate, rapid and long-term results of using Antispike as a drug for preventive adhesions in patients who have a medium and high risk factor for the development of adhesions and are undergoing surgery for acute phlegmonous appendicitis;\n* Identify the possibility of undesirable effects that may occur when using the drug;\n* to conduct a comparative assessment of the immediate results of using the drug Antispike as a means of preventing adhesions in patients with minor phlegmonous appendicitis with an effect in the control group, in patients in whom anti-adhesion drugs were not used;\n* Detailed description of the conditions and method of use of the Antispike drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of acute phlegmonous appendicitis requiring surgical intervention.\n* Presence of medium or high risk factor for the development of adhesions of the abdominal cavity;\n* Age of patients from 18 to 65 years.\n* Absence of severe concomitant diseases in decompensation stage, oncologic diseases, as well as diseases requiring steroid therapy.\n* Presence of written informed consent of the patient to participate in the study.\n* The patient's ability to fulfill the instructions of the research physician and comply with the study design.\n\nExclusion Criteria:\n\n* At the subject own request without explaining the reasons for the behavior.\n* At the request of the physician-researcher if the subject violates the requirements of the protocol in terms of diet, smoking, consumption of alcoholic beverages, and use of medications without the prescription of the physician-researcher.\n* For reasons independent of the subject and the research physician, if the subject has drug intolerance or other life-threatening or life-threatening adverse reactions to drug administration that require emergency pharmacotherapy."}, 'identificationModule': {'nctId': 'NCT06365632', 'acronym': 'OLTOSPAN-02', 'briefTitle': 'Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis', 'organization': {'class': 'OTHER', 'fullName': 'Research Institute for Physical Chemical Problems of the Belarusian State University'}, 'officialTitle': 'A Prospective, Randomized, Parallel, Single-blind Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", Belarus, With a Single Intraperitoneal Use After Surgical Interventions in Adult Patients With Acute Phlegmonous Appendicitis', 'orgStudyIdInfo': {'id': 'OLTOSPAN-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical intervention due to acute phlegmanous appendicitis using the drug antispike', 'description': 'Placebo-controlled, single-blind clinical trial of the effectiveness, tolerability and safety of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BGU, Republic of Belarus, in adult patients after surgery for acute phlegmonous appendicitis. An antegrade appendectomy is performed, after which the drug Antispike is used.', 'interventionNames': ['Drug: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus', 'Procedure: antegrade appendectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'surgical intervention due to acute phlegmanous appendicitis', 'description': 'An antegrade appendectomy is performed without using Antispike.', 'interventionNames': ['Procedure: antegrade appendectomy']}], 'interventions': [{'name': 'Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus', 'type': 'DRUG', 'description': 'An antegrade appendectomy is performed, after which 50 to 100 ml of Antispike is applied in a thin layer to the surface of the cecum, the surface of adjacent organs and the parietal peritoneum of the right iliac region. The wound is sutured tightly.', 'armGroupLabels': ['Surgical intervention due to acute phlegmanous appendicitis using the drug antispike']}, {'name': 'antegrade appendectomy', 'type': 'PROCEDURE', 'description': 'An antegrade appendectomy is performed without using Antispike.', 'armGroupLabels': ['Surgical intervention due to acute phlegmanous appendicitis using the drug antispike', 'surgical intervention due to acute phlegmanous appendicitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220024', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'CITY CLINICAL EMERGENCY HOSPITAL of Minsk', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Institute for Physical Chemical Problems of the Belarusian State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unitary Enterprise UNITEHPROM BSU', 'class': 'UNKNOWN'}, {'name': 'City Clinical Hospital of Emergency Medical Care of Minsk', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}