MedTrace Logo

Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing

NCT04598880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1180

Last updated 2026-05-14

No results posted yet for this study

Summary

Background:

Colorectal cancer is the most frequent neoplasm and the second cause of cancer death in Spain. Colon cleansing is critical for visualization of lesions at colonoscopy. High-quality cleansing allows for correct detection and resection of all lesions and may contribute to adequate risk stratification and follow-up interval.

Low-volume laxatives improve tolerance of the colonoscopy preparation without reducing its effectiveness. Currently, the most widely used low-volume laxatives are one liter of Polyethylene glycol + ascorbate (PEG1A) and sodium picosulfate + magnesium citrate (PSCM).

The evidence on the comparison of laxatives to achieve a high-quality colonic cleansing is very scarce.

Hypothesis:

Polyethylene glycol 1 liter with ascorbate is superior to sodium picosulfate and magnesium citrate in high-quality colon cleansing.

Objective:

Overall objective:

To compare the global high-quality cleansing frequency between the two laxatives using the Harefield Scale (HS).

The primary objective is to demonstrate non-inferiority in global high-quality cleansing of PEG1A compared to PSCM. If non-inferiority is demonstrated, superiority of PEG1A will be analyzed.

Specific objectives:

* Frequency of global high-quality cleansing using the Boston Bowel Preparation Scale (BBPS).
* Frequency of adequate-quality cleansing using the HS and BBPS scales.
* Tolerance and adverse effects of both laxatives.
* Detection of lesions, total adenomas, advanced adenomas, total serrated lesions, advanced serrated lesions and colorectal cancer.
* Detection of neoplastic lesions in the different colon segments (proximal, transverse, descending, sigmoid and rectum).
* Association between detected lesions and the quality of the preparation, according to the HS and BBPS scales.

Methods:

Phase 4, multi-centric, randomized, single-blind (endoscopist), parallel study with two treatment arms: PEG1A (Pleinvue®) and PSCM (Citrafleet®).

Conditions

  • Colonic Diseases

Interventions

DRUG

Polyethylene glycol + ascorbate

Pleinvue® is administered orally in 2 doses (3 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose is administered at 9 pm on the day before intervention (sachet 1: MACROGOL 3350 100 g + SODIUM SULFATE ANHYDROUS 9 g + SODIUM CHLORIDE 2 g + POTASSIUM CHLORIDE 1 g). Second dose is administered 5 hours before intervention and it is composed by 2 sachets (sachet A: MACROGOL 3350 40 g + SODIUM CHLORIDE 3,2 g + POTASSIUM CHLORIDE 1,2 g; sachet B: SODIUM ASCORBATE 48,11 g + ASCORBIC ACID 7,54 g).

DRUG

Sodium picosulfate + magnesium citrate

Citrafleet® is administered orally in 2 doses (2 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose (sachet 1) is administered at 9 pm on the day before intervention. Second dose (sachet 2) is administered 5 hours before intervention. Sachets 1 and 2 have the same composition: SODIUM PICOSULFATE 10 mg + MAGNESIUM OXIDE 3,5 g + CITRIC ACID 10,97 g.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Marco Antonio Alvarez González, MD, PhD · Hospital del Mar (Barcelona, Spain)

  • Eduardo Albéniz, MD, PhD · Complejo Hospitalario de Navarra (Pamplona, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04598880 on ClinicalTrials.gov