SODIUM HYDROGEN CARBONATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; MACROGOL 3350 for Inadequate bowel preparation

Inclusion criteria

• {"criterion_text":"- Women and/or men at least 18 years old\n- Women and/or men with inadequate preparation on reference colonoscopy, score <6 points according to the Boston Bowel Preparation Scale (BBPS)\n- Patients who are legally competent and capable of understanding the information provided about the study, have been informed about the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF)."}

Exclusion criteria

• {"criterion_text":"- Common contraindications for colonoscopy (suspected perforation, toxic megacolon, pyloric stenosis, severe colitis, pregnancy, lactation)\n- Type I diabetes\n- Patients with colon segmental resection\n- Patients suffering from severe dehydration\n- Rhabdomyolysis\n- Hypermagnesemia\n- Patients suffering from active inflammatory bowel disease\n- Intestinal obstruction or perforation\n- Ileus, gastric retention, acute intestinal or gastric ulceration\n- Acute abdominal conditions requiring immediate surgery, such as acute appendicitis\n- Nausea and vomiting\n- Allergy or hypersensitivity to study drugs\n- Toxic megacolon\n- Non-compliance with instructions for bowel preparation during reference colonoscopy (receiving <75% of bowel preparation)\n- Polyposis syndrome and refusal to participate in the study\n- Pregnancy\n- Lactation\n- Participation in another study of an investigational medicinal product or investigational medical device\n- Severe heart failure (NYHA III/IV)\n- Severe chronic kidney disease (eGFR<30)"}

Primary endpoints

• {"endpoint_text":"- Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.","definition_or_measurement_approach":"Defined by Boston Bowel Preparation Scale (BBPS): total BBPS score ≥6 and per-segment score ≥2."}

Secondary endpoints

• {"endpoint_text":"- Average BBPS total score\n- Partial BBPS sub-score for the right (ascending) colon\n- Polyp detection rate\n- Percentage of colonoscopies reaching the cecum\n- Patient tolerance, which will be assessed based on a questionnaire assessing the tolerance of the preparation translated and updated in Greek","definition_or_measurement_approach":"Average and partial scores measured using the Boston Bowel Preparation Scale (BBPS); polyp detection rate measured as proportion of procedures with polyps detected; percentage reaching the cecum measured as proportion of colonoscopies reaching the cecum; patient tolerance assessed by a translated questionnaire (patient-reported tolerance)."}

Greece

Earliest CTIS Part Ii Submission Date

15-04-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

94

Number Of Sites

4

Number Of Participants

188

Primary sponsor

Full Name

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece