Colonoscopy bowel preparation MedDRA version: 20.1 Level: HLT Classification code 10017963 Term: Gastrointestinal and abdominal imaging procedures System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Citrafleet por belsoleges oldathoz
Product Name: CitraFleet por belsoleges oldathoz
Pharmaceutical Form: Powder for oral solution in sachet
Sponsors
Goodwill Pharma Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age between 18 and 80 years 2. patients scheduled to undergo colonoscopy at Endoscopy Unit of First Department of Internal Medicine at University of Szeged. 3. signed Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. chronic kidney disease, 2. severe heart failure (New York Heart Association [NYHA] class III or IV), 3. uncontrolled hypertension (systolic pressure =170 mm Hg, diastolic pressure =100 mm Hg), 4. severe constipation, 5. any bowel resection, 6. significant gastroparesis, or suspected bowel obstruction or perforation, 7. hypersensitivity to the active substances or to any of the excipients, 8. severe dehydration, 9. hypermagnesaemia, 10. gastric retention, 11. gastro-intestinal ulceration, 12. toxic colitis, toxic megacolon, 13. ascites, 14. acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation, 15. active inflammatory bowel disease, 16. rhabdomyolysis, 17. pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure efficacy of CitraFleet by using Boston Bowel Preparation Scale.; Secondary Objective: • To measure safety of CitraFleet. • To determine patient’s opinion about the tolerability and other qualities: taste, possible side effects (excessive thirst, nausea, vomiting, bloating, abdominal pain and cramps, headache, dizziness, sleep disturbance) of CitraFleet. ;Primary end point(s): The efficacy of CitraFleet will be measured using the Boston Bowel Preparation Scale by the ratio of patients achieving appropriate cleaning. ;Timepoint(s) of evaluation of this end point: Colonscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To assess the safety of CitraFleet serum parameters (Na, K, UN and creatinine) will be assessed before and after the cleansing. - To determine patient’s opinion about the tolerability and other qualities: taste, possible side effects (excessive thirst, nausea, vomiting, bloating, abdominal pain and cramps, headache, dizziness, sleep disturbance) of CitraFleet a patient reported questionnaire will be used. ; Timepoint(s) of evaluation of this end point: - Laboratory parameters will be assessed before and after cleansing - Patient tolerability questionnaire will be completed by the patient once after cleansing. | — |
Countries
Hungary
Contacts
Public ContactDQPPV
Goodwill Pharma Kft
Outcome results
None listed