SIMETICONE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM CITRATE; SODIUM SULFATE ANHYDROUS; MACROGOL 4000; CITRIC ACID for Colorectal cancer|Colorectal adenoma

Stratification factors

• sex
• age

Inclusion criteria

• {"criterion_text":"- Men and women aged 50 to 69.\n- Have participated in the early detection program for colorectal cancer.\n- Positive result in the fecal occult blood test (≥20 μg Hb/g feces).\n- Scheduled screening colonoscopy at Hospital Clínic de Barcelona.\n- Signed informed consent form."}

Exclusion criteria

• {"criterion_text":"- Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).\n- Hypermagnesemia.\n- Rhabdomyolysis.\n- Phenylketonuria.\n- Glucose-6-phosphate dehydrogenase deficiency.\n- Hypersensitivity to the active ingredients of excipients.\n- Pregnancy or breastfeeding.\n- Colonoscopy within the last year.\n- Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).\n- Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).\n- Do not understand spoken or written Catalan or Spanish.\n- Partial or total colon resection.\n- Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).\n- Terminal illness or serious illness/disability that contraindicates subsequent colon study.\n- Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon)."}

Primary endpoints

• {"endpoint_text":"- Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).","definition_or_measurement_approach":"Defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group."}

Secondary endpoints

• {"endpoint_text":"- Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.","definition_or_measurement_approach":"Defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group."}
• {"endpoint_text":"- Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.","definition_or_measurement_approach":"Defined as the mean number of adenomas detected by colonoscopy in the subjects in each group."}
• {"endpoint_text":"- The presence of foam and bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).","definition_or_measurement_approach":"Presence of foam and bubbles assessed by CEBuS; each colonic segment scored 0–2 as defined."}
• {"endpoint_text":"- The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.","definition_or_measurement_approach":"Assessed by Boston Scale; each segment scored 0–3; adequacy defined as total score ≥6 and ≥2 in each segment."}
• {"endpoint_text":"- Need for washing tools during colonoscopy. The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted. Likewise, the volume of simethicone used will be counted if it is considered necessary.","definition_or_measurement_approach":"Measured by amount of wash water used and volume of simethicone used during colonoscopy."}
• {"endpoint_text":"- Cecal intubation rate. The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.","definition_or_measurement_approach":"Proportion of colonoscopies reaching the cecum (complete) versus not (incomplete)."}
• {"endpoint_text":"- Cecal intubation time. Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.","definition_or_measurement_approach":"Time from introduction of endoscope to reaching cecal fundus."}
• {"endpoint_text":"- Endoscope removal time. Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.","definition_or_measurement_approach":"Time from reaching cecal fundus to completion of endoscopy, including cleaning time and excluding lesion treatment."}
• {"endpoint_text":"- Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale.","definition_or_measurement_approach":"Proportion requiring repeat colonoscopy due to Boston Scale total <6 or <2 in any segment."}
• {"endpoint_text":"- Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Annex 3, Tolerability and satisfaction questionnaire).","definition_or_measurement_approach":"Assessed via tolerability and satisfaction questionnaire categorising adherence into defined degrees."}
• {"endpoint_text":"- Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Annex 3, Tolerability and satisfaction questionnaire).","definition_or_measurement_approach":"Numerical rating scale 0–10 from questionnaire."}
• {"endpoint_text":"- Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Annex 3, Tolerability and satisfaction questionnaire).","definition_or_measurement_approach":"Numerical rating scale 0–10 from questionnaire."}
• {"endpoint_text":"- Willingness to repeat the intake of the preparation assessed as yes or no (Annex 3, Tolerability and satisfaction questionnaire).","definition_or_measurement_approach":"Binary yes/no response from questionnaire."}
• {"endpoint_text":"- Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Annex 3, Tolerability and satisfaction questionnaire).","definition_or_measurement_approach":"Numerical rating scale 0–10 from questionnaire."}
• {"endpoint_text":"- Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Annex 4, Data collection form).","definition_or_measurement_approach":"Endoscopist numerical rating scale 0–10 recorded on data collection form."}
• {"endpoint_text":"- Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Annex 3, Tolerability and Satisfaction Questionnaire).","definition_or_measurement_approach":"Adverse event rate assessed via tolerability and satisfaction questionnaire listing specified symptoms."}

Spain

Earliest CTIS Part Ii Submission Date

23-01-2026

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

818

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Alfasigma España S.L.","duties_or_roles":"Monetary support","organisation_type":""}