An observational study in Chronic Cholecystitis, sponsored by Kazakhstan Scientific Society for Study of intestine diseases. Not yet recruiting at 15 sites in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Kazakhstan Scientific Society for Study of intestine diseases · Observational
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.
This study's planned enrollment of 169 is below the median of 222 across 55 observational studies indexed under Cholecystitis.
Browse Cholecystitis studies →Kazakhstan Scientific Society for Study of intestine diseases is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients of both sexes aged ≥18 to 65 years inclusive with a verified diagnosis: chronic acalculous cholecystitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms
Time frame: on day 21
Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire
Time frame: on day 21
Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire
Time frame: on day 21
Incidence of SUSAR
Time frame: on day 21
The dynamics of Aspartate aminotransferase
Time frame: on day 21
The dynamics of Alanine aminotransferase
Time frame: on day 21
The dynamics of Alkaline phosphatase
Time frame: on day 21
The dynamics of Gamma-glutamyl transpeptidase
Time frame: on day 21
The dynamics of bilirubin with fractions
Time frame: on day 21
Types of concomitant therapy uses
Time frame: on day 21
Frequency of use of concomitant therapy
Time frame: on day 21
Assessment of the shape of the gallbladder by ultrasound
Time frame: on day 21
Assessment of the size of the gallbladder by ultrasound
Time frame: on day 21
Assessment of the thickness of the gallbladder walls by ultrasound
Time frame: on day 21
Assessment of the presence of intraluminal formations of the bladder by ultrasound
Time frame: on day 21
Assessment of the presence of an acoustic shadow by ultrasound
Time frame: on day 21
Assessment of the mobility of intraluminal formations by ultrasound
Time frame: on day 21
Assessment of the presence of biliary sludge by ultrasound
Time frame: on day 21
Assessment of the size of the common bile duct by ultrasound
Time frame: on day 21
Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound
Time frame: on day 21
Assessment of the presence of additional formations using ultrasound
Time frame: on day 21
Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.
Of 23 observational studies under Cholecystitis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kazakhstan Scientific Society for Study of intestine diseases