Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy

Recruiting now · Phase 4

Conditions studied: Colorectal Cancer Early Detection

In brief

Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.

Key facts

Study ID

NCT07696793

Run by

Fundacion Clinic per a la Recerca Biomédica

People needed

818

Starts

2026-05-18

Expected to finish

2028-05-01

Last updated by the study team

2026-07-10

Who can join

Age: 50 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Clínic de Barcelona — Barcelona, Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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