Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
6. juli 2026 oppdatert av: Fundacion Clinic per a la Recerca Biomédica
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
818
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Maria Pellisé
- Telefonnummer: +34 932275400
- E-post: MPELLISE@clinic.cat
Studer Kontakt Backup
- Navn: Judit Pich
- Telefonnummer: 2815 +34 932275400
- E-post: JPICH@recerca.clinic.cat
Studiesteder
-
-
Barcelona
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Barcelona, Barcelona, Spania, 08036
- Rekruttering
- Hospital Clinic de Barcelona
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Hovedetterforsker:
- Maria Pellisé
-
Ta kontakt med:
- Maria Pellisé
- E-post: MPELLISE@clinic.cat
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Clensia®
Clensia®, powder for oral solution in sachet.
To be taken 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.
|
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.
|
|
Eksperimentell: Citrafleet®
Citrafleet®, powder for oral solution in sachet.
To be taken 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.
|
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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adenoma detection rate
Tidsramme: week 2 (Colonoscopy visit)
|
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)).
|
week 2 (Colonoscopy visit)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Lesion detection rate
Tidsramme: week 2 (Colonoscopy visit)
|
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.
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week 2 (Colonoscopy visit)
|
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Adenomas per colonoscopy
Tidsramme: week 2 (Colonoscopy visit)
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
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week 2 (Colonoscopy visit)
|
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Presence of foam
Tidsramme: week 2 (Colonoscopy visit)
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The presence of foam 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).
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week 2 (Colonoscopy visit)
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Presence of bubbles
Tidsramme: week 2 (Colonoscopy visit)
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The presence of 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).
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week 2 (Colonoscopy visit)
|
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Quality of colon cleansing
Tidsramme: week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
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Need for washing tools during colonoscopy
Tidsramme: week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
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Cecal intubation rate
Tidsramme: week 2 (Colonoscopy visit)
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Cecal intubation rate.
The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
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week 2 (Colonoscopy visit)
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Cecal intubation time
Tidsramme: week 2 (Colonoscopy visit)
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Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
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week 2 (Colonoscopy visit)
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Endoscope removal time
Tidsramme: week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
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Requires repeat colonoscopy due to poor preparation
Tidsramme: week 2 (Colonoscopy visit)
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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
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week 2 (Colonoscopy visit)
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Adherence to the intake of the preparation
Tidsramme: week 2 (Colonoscopy visit)
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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 (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Ease of taking the preparation
Tidsramme: week 2 (Colonoscopy visit)
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Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Palatability of the preparation
Tidsramme: week 2 (Colonoscopy visit)
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Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Willingness to repeat the intake of the preparation
Tidsramme: week 2 (Colonoscopy visit)
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Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Overall satisfaction with the intake of the preparation
Tidsramme: week 2 (Colonoscopy visit)
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Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
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Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
Tidsramme: week 2 (Colonoscopy visit)
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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 (Data collection form).
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week 2 (Colonoscopy visit)
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Rate of adverse events
Tidsramme: week 2 (Colonoscopy visit) and week 4 (visit 2)
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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 (Tolerability and Satisfaction Questionnaire).
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week 2 (Colonoscopy visit) and week 4 (visit 2)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. mai 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. mai 2028
Datoer for studieregistrering
Først innsendt
26. september 2025
Først innsendt som oppfylte QC-kriteriene
6. juli 2026
Først lagt ut (Faktiske)
10. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2025-523748-11-00
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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Nei
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