Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06516718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-24
First Post:
2024-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms', 'timeFrame': 'on day 21'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire', 'timeFrame': 'on day 21'}, {'measure': 'Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire', 'timeFrame': 'on day 21'}, {'measure': 'Incidence of SUSAR', 'timeFrame': 'on day 21'}, {'measure': 'The dynamics of Aspartate aminotransferase', 'timeFrame': 'on day 21'}, {'measure': 'The dynamics of Alanine aminotransferase', 'timeFrame': 'on day 21'}, {'measure': 'The dynamics of Alkaline phosphatase', 'timeFrame': 'on day 21'}, {'measure': 'The dynamics of Gamma-glutamyl transpeptidase', 'timeFrame': 'on day 21'}, {'measure': 'The dynamics of bilirubin with fractions', 'timeFrame': 'on day 21'}, {'measure': 'Types of concomitant therapy uses', 'timeFrame': 'on day 21'}, {'measure': 'Frequency of use of concomitant therapy', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the shape of the gallbladder by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the size of the gallbladder by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the thickness of the gallbladder walls by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the presence of intraluminal formations of the bladder by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the presence of an acoustic shadow by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the mobility of intraluminal formations by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the presence of biliary sludge by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the size of the common bile duct by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound', 'timeFrame': 'on day 21'}, {'measure': 'Assessment of the presence of additional formations using ultrasound', 'timeFrame': 'on day 21'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Cholecystitis']}, 'descriptionModule': {'briefSummary': 'Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 65 years;\n* BMI 18.5 - 40;\n* Verified diagnosis: chronic acalculous cholecystitis;\n* Voluntary desire to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Presence of stones in the gall bladder and bile ducts;\n* The presence of jaundice, cholestatic liver diseases, liver cirrhosis with decompensation;\n* Increased ALT, AST above the 3 upper limits of normal;\n* Hypersensitivity to the components of the drug Odeston;\n* Pregnancy and lactation;\n* Prolonged fasting and total parenteral nutrition;\n* Patients with symptoms of acute abdomen at the time of inclusion in the study;\n* Patients with symptoms of acute neurological pathology at the time of inclusion in the study and/or аcute cerebrovascular accident, a history of convulsive syndrome;\n* Presence of cancer;\n* Acute infectious diseases at the time of inclusion in the study;\n* Fever of any origin (above 37.5 C);\n* Patients with symptoms of heart failure;\n* Patients with symptoms of pulmonary failure;\n* Patients with symptoms of acute or chronic renal failure;\n* A decompensated form of diabetes;\n* Patients with signs of psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06516718', 'briefTitle': 'An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Kazakhstan Scientific Society for Study of intestine diseases'}, 'officialTitle': 'Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice', 'orgStudyIdInfo': {'id': 'UO-KSSSID-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '055990', 'city': 'Almaty', 'country': 'Kazakhstan', 'contacts': [{'name': 'Sultan Z.K.', 'role': 'CONTACT', 'email': 'zashenova75@mail.ru', 'phone': '+7 (727) 292-51-51'}], 'facility': '"Human Health Clinic" LLP', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '055990', 'city': 'Almaty', 'country': 'Kazakhstan', 'contacts': [{'name': 'Marat Pashimov', 'role': 'CONTACT', 'email': 'priem-dir@ncvb.kz', 'phone': '+7(727)233-00-23'}], 'facility': 'JSC "Research institute of cardiology and internal disease"', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'zip': '055990', 'city': 'Almaty', 'country': 'Kazakhstan', 'contacts': [{'name': 'Kambarova G.A.', 'role': 'CONTACT', 'email': 'gkkp5@inbox.ru', 'phone': '8 (727) 233-39-62'}], 'facility': 'State-owned public enterprise with the right of economic management City Clinic No. 5', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}, {'city': 'Astana', 'country': 'Kazakhstan', 'contacts': [{'name': 'Khutiev S.Ya.', 'role': 'CONTACT', 'email': 'beisenbayev_e@mail.ru', 'phone': '+7(777)017-10-07'}], 'facility': '"Taimas Medical" LLP', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'city': 'Astana', 'country': 'Kazakhstan', 'contacts': [{'name': 'Otepova G.D.', 'role': 'CONTACT', 'email': 'ole_olya2019@mail.ru', 'phone': '+7(7172) 36 02 49'}], 'facility': 'Medical center "Aiya"', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'city': 'Astana', 'country': 'Kazakhstan', 'contacts': [{'name': 'Albaev R.K.', 'role': 'CONTACT', 'email': 'bmcudpportal@bmc.mcudp.kz', 'phone': '+7 (7172) 70-80-90'}], 'facility': "Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan", 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'city': 'Astana', 'country': 'Kazakhstan', 'contacts': [{'name': 'Nadyrov K.T.', 'role': 'CONTACT', 'email': 'rektorat@amu.kz', 'phone': '+77001539447'}], 'facility': 'NpJSC "Astana Medical University"', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'city': 'Kyzylorda', 'country': 'Kazakhstan', 'contacts': [{'name': 'Baimakhanov Zh.B.', 'role': 'CONTACT', 'phone': '+7 (7242)23-51-50'}], 'facility': 'State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department', 'geoPoint': {'lat': 44.85278, 'lon': 65.50917}}, {'city': 'Shymkent', 'country': 'Kazakhstan', 'contacts': [{'name': 'Aitbaev D.S.', 'role': 'CONTACT', 'phone': '+77052830192'}], 'facility': '"Treatment Center No. 14" LLP', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'city': 'Shymkent', 'country': 'Kazakhstan', 'contacts': [{'name': 'Myrzakhmetova Sh.I.', 'role': 'CONTACT', 'email': 'info@diagnostik.kz', 'phone': '+7 (7252) 99-78-78'}], 'facility': 'City diagnostic center of Shymkent', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'city': 'Shymkent', 'country': 'Kazakhstan', 'contacts': [{'name': 'Svanova Zh.B.', 'role': 'CONTACT', 'email': 'eskulap_vita@mail.ru', 'phone': '+7 (7252) 57 35 61'}], 'facility': 'Medical Center "Aesculapius Vita"', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'city': 'Shymkent', 'country': 'Kazakhstan', 'contacts': [{'name': 'Stamkulov B.E.', 'role': 'CONTACT', 'email': 'rps0609@mail.ru', 'phone': '8(72533) 46703'}], 'facility': 'State-owned public enterprise with the right of economic management "District polyclinic Sauran" of the Department of Public Health of the Turkestan region', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'city': 'Taraz', 'country': 'Kazakhstan', 'contacts': [{'name': 'Pogrebovsky V.M.', 'role': 'CONTACT', 'phone': '+77018794800'}], 'facility': '"Comec Medical Company" Llp', 'geoPoint': {'lat': 42.89799, 'lon': 71.37334}}, {'city': 'Taraz', 'country': 'Kazakhstan', 'contacts': [{'name': 'Mamedov', 'role': 'CONTACT', 'phone': '+77018794800'}], 'facility': '"Hayat Medical Group" LLP Diagnostic Center', 'geoPoint': {'lat': 42.89799, 'lon': 71.37334}}, {'city': 'Taraz', 'country': 'Kazakhstan', 'contacts': [{'name': 'Maidanov O.K.', 'role': 'CONTACT', 'phone': '+7(7262) 55 67 55'}], 'facility': 'Medical Center "Meyirim"', 'geoPoint': {'lat': 42.89799, 'lon': 71.37334}}], 'centralContacts': [{'name': 'Kanat Khazhidinov', 'role': 'CONTACT', 'email': 'kanat.khazhidinov@smo-mera.kz', 'phone': '+7 707 413 8263'}, {'name': 'Yekaterina Sakhabutdinova', 'role': 'CONTACT', 'email': 'yekaterina.sakhabutdinova@smo-mera.kz', 'phone': '+7 707 375 8530'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kazakhstan Scientific Society for Study of intestine diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}