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Recruiting NCT07696793

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

Phase IV Interventional Colorectal Cancer Early Detection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clensia®, Citrafleet®.
Who it may be relevant to
Registry conditions: Colorectal Cancer Early Detection. Basic parameters: 50 years — 69 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+

Overview

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

Interventions

  • Drug Clensia®
    Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
  • Drug Citrafleet®
    Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.

Primary outcome measures

  • Adenoma detection rate [Time frame: week 2 (Colonoscopy visit)]
Secondary outcome measures (12)
  • Lesion detection rate [Time frame: week 2 (Colonoscopy visit)]
  • Adenomas per colonoscopy [Time frame: week 2 (Colonoscopy visit)]
  • Presence of foam [Time frame: week 2 (Colonoscopy visit)]
  • Presence of bubbles [Time frame: week 2 (Colonoscopy visit)]
  • Quality of colon cleansing [Time frame: week 2 (Colonoscopy visit)]
  • Need for washing tools during colonoscopy [Time frame: week 2 (Colonoscopy visit)]
  • Cecal intubation rate [Time frame: week 2 (Colonoscopy visit)]
  • Cecal intubation time [Time frame: week 2 (Colonoscopy visit)]
  • Endoscope removal time [Time frame: week 2 (Colonoscopy visit)]
  • Requires repeat colonoscopy due to poor preparation [Time frame: week 2 (Colonoscopy visit)]
  • Adherence to the intake of the preparation [Time frame: week 2 (Colonoscopy visit)]
  • Ease of taking the preparation [Time frame: week 2 (Colonoscopy visit)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Spain · 1 center
  • Hospital Clínic de Barcelona — Barcelona

Identifiers

NCT: NCT07696793 · 2025-523748-11-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗