Efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy: a randomized parallel comparative trial. CLEAN+

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

18 May 2026 → ongoing

Decision date (initial)

2026-02-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alfasigma España S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the clinical efficacy of Clensia® versus Citrafleet®, measured by adenoma detection rate, in patients undergoing colorectal cancer screening colonoscopy.

Secondary objectives 7

1. To compare the Lesion Detection Rate between Clensia® and Citrafleet®.
2. To compare the clinical efficacy between Clensia® and Citrafleet® in individuals undergoing colonoscopy in an CCR screening programme.
3. To compare the presence of foam and bubbles (CEBus scale) between Clensia® and Citrafleet®.
4. To compare the quality of colonic cleaning (Boston classification) between Clensia® and Citrafleet®.
5. To evaluate the correlation between colonic cleaning quality and clinical efficacy overall and in each product.
6. To compare adherence, tolerability and satisfaction between Clensia® and Citrafleet®.
7. To compare the Adverse Event Rate between Clensia® and Citrafleet®.

Conditions and MedDRA coding

colorectal cancer early detection

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Men and women aged 50 to 69.
2. Have participated in the early detection program for colorectal cancer.
3. Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
4. Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
5. Signed informed consent form.

Exclusion criteria 15

1. 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).
2. Colonoscopy within the last year.
3. 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).
4. 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).
5. Do not understand spoken or written Catalan or Spanish.
6. Partial or total colon resection.
7. Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
8. Terminal illness or serious illness/disability that contraindicates subsequent colon study.
9. Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
10. Hypermagnesemia.
11. Rhabdomyolysis.
12. Phenylketonuria.
13. Glucose-6-phosphate dehydrogenase deficiency.
14. Hypersensitivity to the active ingredients of excipients.
15. Pregnancy or breastfeeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).

Secondary endpoints 16

1. Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.
2. Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
3. The presence of foam and bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
4. The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent). A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.
5. Need for washing tools during colonoscopy. The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted. Likewise, the volume of simethicone used will be counted if it is considered necessary.
6. Cecal intubation rate. The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
7. Cecal intubation time. Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
8. Endoscope removal time. Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.
9. Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale.
10. Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Annex 3, Tolerability and satisfaction questionnaire).
11. Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Annex 3, Tolerability and satisfaction questionnaire).
12. Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Annex 3, Tolerability and satisfaction questionnaire).
13. Willingness to repeat the intake of the preparation assessed as yes or no (Annex 3, Tolerability and satisfaction questionnaire).
14. Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Annex 3, Tolerability and satisfaction questionnaire).
15. Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Annex 4, Data collection form).
16. Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Annex 3, Tolerability and Satisfaction Questionnaire).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Maria Pellisé

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Maria Pellisé

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications