Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy
Recruiting
50 years - 69 years
All
Phase
4
818 participants needed
1 Location
Brief description of study.
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Colorectal Cancer Early Detection
-
Age: 50 years - 69 years
-
Gender: All
Inclusion Criteria:
- Men and women aged 50 to 69.
- 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 Criteria:
- 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).
- Colonoscopy within the last year.
- 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).
- 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).
- Do not understand spoken or written Catalan or Spanish.
- Partial or total colon resection.
- Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
- 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).
- Hypermagnesemia.
- Rhabdomyolysis.
- Phenylketonuria.
- Glucose-6-phosphate dehydrogenase deficiency.
- Hypersensitivity to the active ingredients of excipients.
- Pregnancy or breastfeeding.
Updated on
06 Jul 2026.
Study ID: 2025-523748-11-00
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