Comparative Efficacy and Tolerability of a Simethicone-Containing Macrogol 4000 Combination Therapy versus Sodium Picosulfate for Colorectal Cancer Screening Colonoscopy

The primary objective of this study is to compare the clinical efficacy of Clensia® versus Citrafleet® in patients undergoing colonoscopy for colorectal cancer screening, as measured by the adenoma detection rate. The secondary objectives include:

• Comparison of the lesion detection rate between the two agents.
• Evaluation of clinical efficacy in individuals participating in a screening program.
• Assessment of the presence of foam and bubbles using the CEBus scale.
• Comparison of colonic cleaning quality via the Boston classification.
• Analysis of the correlation between cleaning quality and clinical efficacy.
• Evaluation of adherence, tolerability, and patient satisfaction.
• Comparison of the adverse event rate.

The sponsor did not provide information regarding the total number of participants. The study population consists of male and female patients aged 50 to 69 years. Participants are selected based on their involvement in a colorectal cancer early detection program and a positive fecal occult blood test result of ≥20 μg Hb/g feces. Inclusion requires a scheduled screening colonoscopy and a signed informed consent form.

This Phase IV, randomized, parallel, comparative trial is designed to evaluate the efficacy and tolerability of two different evacuating solutions for colorectal cancer screening colonoscopy. The study will compare Clensia, a simethicone-containing oral solution, against Citrafleet. The primary endpoint is the adenoma detection rate, which represents the proportion of patients with at least one adenoma. Secondary outcomes include the lesion detection rate, the Boston Scale score for bowel preparation quality, the presence of bubbles assessed via the CEBuS scale, and various measures of tolerability and patient satisfaction. The study is expected to run from January 2026 to January 2028. The research methodology involves a screening process to identify eligible participants based on age and a positive fecal occult blood test. Following enrollment, subjects will undergo the procedure to determine clinical outcomes. The trial focuses on comparing the performance of the two investigative products in a clinical setting.

The experimental medication, Clensia, is administered as an oral solution prepared from a powder. The formulation contains simethicone, potassium chloride, sodium chloride, sodium citrate, sodium sulfate anhydrous, macrogol 4000, and citric acid. The total dose per administration is 112.66 g.

The comparator treatment, CitraFleet, is provided in a powder form for reconstitution as an oral solution in sachets. This formulation consists of sodium picosulfate, magnesium oxide, and citric acid. The administered dose is 30.16 g.

The clinical efficacy of the investigational products is primarily evaluated through the adenoma detection rate, which is calculated as the proportion of patients with at least one adenoma relative to the total number of subjects within each study group. Secondary efficacy parameters include the lesion detection rate, representing the proportion of patients with at least one polyp, and the mean number of adenomas detected per colonoscopy.

The assessment of bowel preparation quality involves several metrics:

• The presence of foam and bubbles is measured using the Colon Endoscopic Bubble Scale (CEBuS), where each colonic segment is scored from 0 to 2 based on the amount of bubbles and their impact on mucosal visibility.
• The Boston Scale is employed to evaluate the quality of colon cleansing, with each segment scored from 0 to 3. Adequate preparation is defined by a total score ≥ 6 and a minimum score of 2 in each segment.
• The requirement for washing tools is quantified by the volume of water and simethicone used during the procedure.
• Procedural completion is monitored via the cecal intubation rate and the cecal intubation time, defined as the duration from endoscope introduction to reaching the cecal fundus.
• The endoscope removal time is measured from the moment the cecal fundus is reached until the completion of the endoscopy, excluding time for lesion treatment.
• The proportion of patients requiring a repeat colonoscopy due to inadequate preparation is determined by Boston Scale scores below the specified thresholds.

Patient-related outcomes and tolerability are assessed via a tolerability and satisfaction questionnaire. This includes adherence to the preparation intake, the ease of taking the preparation, palatability, willingness to repeat the intake, and overall satisfaction, all measured using numerical assessment scales. Furthermore, the rate of adverse events, such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness, and dry mouth, is recorded. Finally, endoscopist's satisfaction regarding the cleaning of faecal remains and bubbles is documented through a numerical assessment scale.