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Evaluation of the effectiveness and tolerance of the macrogol 3350 and electrolytes combination, as a second-line intestinal preparation regimen for colonoscopy with sodium picosulfate/magnesium citrate: a randomized, placebo-controlled, study (PICO-TRAT STUDY)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520818-65-00
Acronym
PICO-TRAT
Enrollment
188
Registered
2025-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second line treatment for colonoscopy preparation

Brief summary

Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.

Detailed description

Average BBPS total score, Partial BBPS sub-score for the right (ascending) colon, Polyp detection rate, Percentage of colonoscopies reaching the cecum, Patient tolerance, which will be assessed based on a questionnaire assessing the tolerance of the preparation translated and updated in Greek

Interventions

DRUGThe placebo has the same composition as the investigational medicinal product Clinitrat® (6.563+175
DRUG4+89
DRUG3+23
DRUG3) mg/sachet (with the exception of the active substance)
DRUGCLINITRAT® (6.563+175
DRUG3) mg/sachet ή stick
DRUGΚόνις για πόσιμο διάλυμα

Sponsors

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Adequate bowel preparation, as defined by a total BBPS score ≥6 and a score per segment ≥2.

Secondary

MeasureTime frame
Average BBPS total score, Partial BBPS sub-score for the right (ascending) colon, Polyp detection rate, Percentage of colonoscopies reaching the cecum, Patient tolerance, which will be assessed based on a questionnaire assessing the tolerance of the preparation translated and updated in Greek

Countries

Greece

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026