Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+
Key facts
- Where
- Barcelona, SpanyolországSee the site
- Phase
- 4. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Trial code
- EU 2025-523748-11-00
- Record updated
- 2026. szeptember 21.
- Original description
To compare the clinical efficacy of Clensia® versus Citrafleet®, measured by adenoma detection rate, in patients undergoing colorectal cancer screening colonoscopy.Read full original descriptionShow less
To compare the clinical efficacy of Clensia® versus Citrafleet®, measured by adenoma detection rate, in patients undergoing colorectal cancer screening colonoscopy.
Inclusion: Men and women aged 49 to 70; Have participated in the early detection program for colorectal cancer; Positive result in the fecal occult blood test (≥20 μg Hb/g feces); Scheduled screening colonoscopy at Hospital Clínic de Barcelona; Signed informed consent form.
Exclusion: Partial or total colon resection; Severe renal failure (grade IV or V) (Annex 5, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 6, NYHA Scale); Hypersensitivity to the active ingredients of excipients; 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); Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease); Terminal illness or serious illness/disability that contraindicates subsequent colon study; Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon); Glucose-6-phosphate dehydrogenase deficiency; Hypermagnesemia; Rhabdomyolysis; Phenylketonuria; Pregnancy or breastfeeding; Colonoscopy within the last year; Barthel Index of <20 (Annex 4, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 7, Rome IV Criteria); Do not understand spoken or written Catalan or Spanish.