An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
1 other identifier
observational
169
1 country
15
Brief Summary
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2024
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2024
CompletedFirst Posted
Study publicly available on registry
July 24, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJuly 24, 2024
July 1, 2024
1 year
July 9, 2024
July 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
on day 21
Secondary Outcomes (20)
Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire
on day 21
Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire
on day 21
Incidence of SUSAR
on day 21
The dynamics of Aspartate aminotransferase
on day 21
The dynamics of Alanine aminotransferase
on day 21
- +15 more secondary outcomes
Eligibility Criteria
Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis
You may qualify if:
- Men and women aged 18 to 65 years;
- BMI 18.5 - 40;
- Verified diagnosis: chronic acalculous cholecystitis;
- Voluntary desire to provide informed consent to participate in the study
You may not qualify if:
- Presence of stones in the gall bladder and bile ducts;
- The presence of jaundice, cholestatic liver diseases, liver cirrhosis with decompensation;
- Increased ALT, AST above the 3 upper limits of normal;
- Hypersensitivity to the components of the drug Odeston;
- Pregnancy and lactation;
- Prolonged fasting and total parenteral nutrition;
- Presence of cancer;
- Fever of any origin (above 37.5 C);
- Patients with symptoms of heart failure;
- Patients with symptoms of pulmonary failure;
- Patients with symptoms of acute or chronic renal failure;
- A decompensated form of diabetes;
- Patients with signs of psychiatric disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
"Human Health Clinic" LLP
Almaty, 055990, Kazakhstan
JSC "Research institute of cardiology and internal disease"
Almaty, 055990, Kazakhstan
State-owned public enterprise with the right of economic management City Clinic No. 5
Almaty, 055990, Kazakhstan
"Taimas Medical" LLP
Astana, Kazakhstan
Medical center "Aiya"
Astana, Kazakhstan
Medical Center Hospital of the President's affairs Administration of the Republic of Kazakhstan
Astana, Kazakhstan
NpJSC "Astana Medical University"
Astana, Kazakhstan
State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department
Kyzylorda, Kazakhstan
"Treatment Center No. 14" LLP
Shymkent, Kazakhstan
City diagnostic center of Shymkent
Shymkent, Kazakhstan
Medical Center "Aesculapius Vita"
Shymkent, Kazakhstan
State-owned public enterprise with the right of economic management "District polyclinic Sauran" of the Department of Public Health of the Turkestan region
Shymkent, Kazakhstan
"Comec Medical Company" Llp
Taraz, Kazakhstan
"Hayat Medical Group" LLP Diagnostic Center
Taraz, Kazakhstan
Medical Center "Meyirim"
Taraz, Kazakhstan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2024
First Posted
July 24, 2024
Study Start
August 1, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
July 24, 2024
Record last verified: 2024-07