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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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