An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice

July 17, 2024 updated by: Kazakhstan Scientific Society for Study of intestine diseases

Post-marketing Observational Clinical Study: 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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 055990
        • "Human Health Clinic" LLP
        • Contact:
      • Almaty, Kazakhstan, 055990
        • JSC "Research institute of cardiology and internal disease"
        • Contact:
      • Almaty, Kazakhstan, 055990
        • State-owned public enterprise with the right of economic management City Clinic No. 5
        • Contact:
          • Kambarova G.A.
          • Phone Number: 8 (727) 233-39-62
          • Email: gkkp5@inbox.ru
      • Astana, Kazakhstan
        • "Taimas Medical" LLP
        • Contact:
      • Astana, Kazakhstan
        • Medical center "Aiya"
        • Contact:
      • Astana, Kazakhstan
        • Medical Center Hospital of the President's Affairs Administration of the Republic of Kazakhstan
        • Contact:
      • Astana, Kazakhstan
        • NpJSC "Astana Medical University"
        • Contact:
      • Kyzylorda, Kazakhstan
        • State-owned public enterprise with the right of economic management "Multidisciplinary regional hospital" of the Kyzylorda Region Health Department
        • Contact:
          • Baimakhanov Zh.B.
          • Phone Number: +7 (7242)23-51-50
      • Shymkent, Kazakhstan
        • "Treatment Center No. 14" LLP
        • Contact:
          • Aitbaev D.S.
          • Phone Number: +77052830192
      • Shymkent, Kazakhstan
        • City diagnostic center of Shymkent
        • Contact:
      • Shymkent, Kazakhstan
        • Medical Center "Aesculapius Vita"
        • Contact:
      • 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
        • Contact:
      • Taraz, Kazakhstan
        • "Comec Medical Company" Llp
        • Contact:
          • Pogrebovsky V.M.
          • Phone Number: +77018794800
      • Taraz, Kazakhstan
        • "Hayat Medical Group" LLP Diagnostic Center
        • Contact:
          • Mamedov
          • Phone Number: +77018794800
      • Taraz, Kazakhstan
        • Medical Center "Meyirim"
        • Contact:
          • Maidanov O.K.
          • Phone Number: +7(7262) 55 67 55

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • Patients with symptoms of acute abdomen at the time of inclusion in the study;
  • 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;
  • Presence of cancer;
  • Acute infectious diseases at the time of inclusion in the study;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
Time Frame: on day 21
on day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire
Time Frame: on day 21
on day 21
Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire
Time Frame: on day 21
on day 21
Incidence of SUSAR
Time Frame: on day 21
on day 21
The dynamics of Aspartate aminotransferase
Time Frame: on day 21
on day 21
The dynamics of Alanine aminotransferase
Time Frame: on day 21
on day 21
The dynamics of Alkaline phosphatase
Time Frame: on day 21
on day 21
The dynamics of Gamma-glutamyl transpeptidase
Time Frame: on day 21
on day 21
The dynamics of bilirubin with fractions
Time Frame: on day 21
on day 21
Types of concomitant therapy uses
Time Frame: on day 21
on day 21
Frequency of use of concomitant therapy
Time Frame: on day 21
on day 21
Assessment of the shape of the gallbladder by ultrasound
Time Frame: on day 21
on day 21
Assessment of the size of the gallbladder by ultrasound
Time Frame: on day 21
on day 21
Assessment of the thickness of the gallbladder walls by ultrasound
Time Frame: on day 21
on day 21
Assessment of the presence of intraluminal formations of the bladder by ultrasound
Time Frame: on day 21
on day 21
Assessment of the presence of an acoustic shadow by ultrasound
Time Frame: on day 21
on day 21
Assessment of the mobility of intraluminal formations by ultrasound
Time Frame: on day 21
on day 21
Assessment of the presence of biliary sludge by ultrasound
Time Frame: on day 21
on day 21
Assessment of the size of the common bile duct by ultrasound
Time Frame: on day 21
on day 21
Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound
Time Frame: on day 21
on day 21
Assessment of the presence of additional formations using ultrasound
Time Frame: on day 21
on day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kazakhstan Scientific Society for Study of intestine diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UO-KSSSID-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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