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

  • STATUS
    Recruiting
  • End date
    May 13, 2028
  • participants needed
    818
  • sponsor
    Fundacion Clinic per a la Recerca Biomédica
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Updated on 13 July 2026
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Summary

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

Details
Condition Colorectal Cancer Early Detection
Age 50years - 69years
Clinical Study IdentifierNCT07696793
SponsorFundacion Clinic per a la Recerca Biomédica
Last Modified on13 July 2026

Eligibility

 Yes No Not Sure

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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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