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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50-69
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Clensia®
  • Citrafleet®

Treatment groups

818 Participants
are divided into 2 treatment groups