CLINICAL TRIAL OF THE NEW SOLUTION OF 1 LITER POLYETHYLENE GLYCOL VERSUS SODIUM PICOSULFATE WITH MAGNESIUM CITRATE IN THE EFFECTIVENESS OF COLONOSCOPY

PRAGMATIC, COMPARATIVE AND RANDOMIZED CLINICAL TRIAL OF THE NEW SOLUTION OF 1 LITER POLYETHYLENE GLYCOL VERSUS SODIUM PICOSULFATE WITH MAGNESIUM CITRATE IN THE EFFECTIVENESS OF SCREENING AND SURVEILLANCE COLONOSCOPY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002562-12-ES

Enrollment

494

Registered

2019-09-04

Start date

2019-09-09

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Screening and surveillance colonoscopy

Interventions

Trade Name: PLEINVUE Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Macrogol 3350 Other descriptive name: MACROGOL 3350

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Screening colonoscopy in older than 50 years old without family history of colorectal cancer Screening colonoscopy in patientes with family history of colorectal cancer Surveillance colonoscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 494 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Family or personal history of colorectal poliposis (familial adenomatous polyposis, etc). Family or personal history of hereditary non-polyposis colorectal cancer (Lynch Syndrome, Familial Colorectal Cancer-Type X)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of a new PEG 1 L versus sodium picosulfate/magnesium citrate administered in split doses using as reference proximal lesions to the splenic flexure: adenoma detection rate and serrated polyps detection rate. ; Secondary Objective: To determine adenoma detection rate in whole colon. - To determine Boston Bowel Preparation Scale - To determine retrieved polyp rate. - To determine cecal intubation rate. - To determine withdrawal time. - To determine intraprocedure complications (perforation and bleeding) - To determine tolerability of citrafleet and each dose of pleinvue. ; Primary end point(s): Adenoma detection rate in right colon Proximal serrated detection rate ;Timepoint(s) of evaluation of this end point: Colonoscopy date	—

Measure

Time frame

Main Objective: To compare the efficacy of a new PEG 1 L versus sodium picosulfate/magnesium citrate administered in split doses using as reference proximal lesions to the splenic flexure: adenoma detection rate and serrated polyps detection rate. ; Secondary Objective: To determine adenoma detection rate in whole colon. - To determine Boston Bowel Preparation Scale - To determine retrieved polyp rate. - To determine cecal intubation rate. - To determine withdrawal time. - To determine intraprocedure complications (perforation and bleeding) - To determine tolerability of citrafleet and each dose of pleinvue. ; Primary end point(s): Adenoma detection rate in right colon Proximal serrated detection rate ;Timepoint(s) of evaluation of this end point: Colonoscopy date

—

Secondary

Measure	Time frame
Secondary end point(s): Adenoma detection rate in whole colon. Satisfaction questionary, Boston Bowel Preparation Scale, retrieved polyp rate, cecal intubation rate, withdrawal time, intraprocedure complications (perforation and bleeding) and tolerability of citrafleet and each dose of pleinvue. ;Timepoint(s) of evaluation of this end point: Colonoscopy date	—

Countries

Spain

Contacts

Public ContactGASTROENTEROLOGY DEPARTMENT

HOSPITAL GENERAL DE CATALUNYA

alvarobendezu@hotmail.com34680117262

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026