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Colonic DiseasesPhase 4NCT04598880

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

A Phase 4 study testing Polyethylene glycol + ascorbate and Sodium picosulfate + magnesium citrate in people with Colonic Diseases, run by Parc de Salut Mar at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Colonic Diseases
What is being tested?
Polyethylene glycol + ascorbate and Sodium picosulfate + magnesium citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,180 participants
Where
14 sitesSpain
Study dates
6 Nov 2020to 1 Apr 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients with previously scheduled colonoscopy with any indication: screening, follow-up, or symptoms.

Who cannot join

  • Age less than 18 years or more than 85 years
  • Hospital admission at the time of colonoscopy
  • Partial or total colectomy
  • Severe constipation
  • Active inflammatory bowel disease
  • Severe kidney or liver failure
Show all 9Show fewer
  • Pregnancy or lactation
  • Inability to understand the instructions by language barrier or cognitive disorder
  • Refusal to participate in the study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Organización Sanitaria Integrada Araba

    Alava

  • Hospital de Poniente

    Almería

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Virgen de las Nieves

    Granada

  • Clínica Universidad de Navarra

    Madrid

  • Hospital de la Princesa

    Madrid

  • Hospital Gregorio Marañón

    Madrid

  • Hospital La Paz

    Madrid

  • Hospital Ramón y Cajal

    Madrid

  • Hospital Quirón

    Málaga

  • Hospital Costa del Sol

    Marbella

  • Hospital Santa Bárbara

    Soria

  • Hospital de Viladecans

    Viladecans, Barcelona

Other trials in Spain

About this study

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.

Read more

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®).

Read the detailed description

This study will be performed in 1104 patients with a scheduled colonoscopy for any indication, who need a bowel preparation for the colonoscopy.

Subjects will be randomly assigned to 1 of 2 treatment groups with a 1:1 allocation using block sizes of 6 cases in each center. The treatment assignment will be open to the participant and the physician. The investigator who performs the colonoscopy and assesses the primary outcome (digestive endoscopist) will be blinded.

In both treatment groups, participants will receive instructions about colonoscopy preparation. Laxative treatment (PEG1A/PSCM) will be administered in two doses, at 9 pm on the day before intervention and 5 hours before colonoscopy, on an outpatient basis.

The day of the colonoscopy appointment will be the final visit of the study. The participant will be asked through a questionnaire about adherence to instructions, tolerance and acceptability to the preparation, and the appearance of side effects. No follow-up period is considered after intervention.

Being tested
Polyethylene glycol + ascorbate, Sodium picosulfate + magnesium citrate
Keywords
Colonoscopy
Medical subject headings
Colonic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polyethylene glycol + ascorbateDrug

    Also called Pleinvue®, PEG1A

    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).

  • Sodium picosulfate + magnesium citrateDrug

    Also called Citrafleet®, PSCM

    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.

Study groups in NCT04598880
Study groupRoleWhat they receive
PleinvueExperimentalSubjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.
Receives: Drug: Polyethylene glycol + ascorbate
CitrafleetExperimentalSubjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.
Receives: Drug: Sodium picosulfate + magnesium citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. High quality of entire colon cleansing according to the HS

    High quality cleansing in the entire colon (global) according to the HS, which is defined as all segments with a score of 3 or 4 points.

    Measured: At the time of colonoscopy

Secondary outcomes (10)

  1. High quality of segmental colon cleansing according to the HS

    High quality cleansing in each segment of colon (segmental) according to the HS, which is defined as a score of 3 or 4 points.

    Measured: At the time of colonoscopy

  2. Successful global and segmental colon cleansing according to the HS

    Successful cleansing at a global and segmental level according to the HS, which is defined as a segmental score >=2 points, and at a global level, as all segments with a score of >=2 points.

    Measured: At the time of colonoscopy

  3. High quality and adequate quality of global and segmental colon cleansing according to the BBPS

    High quality cleansing at a segmental level according to the BBPS, which is defined as a score of 3 points, and at a global level, defined as all segments with a score of 3 points.

    Adequate cleansing at segmental level according to the BBPS, which is defined as a segment with a score >=2 points, and at global level, defined as all segments with a score of >=2 points.

    Measured: At the time of colonoscopy

  4. Demographic variables

    Collected through an anamnesis in a structured interview at the beginning of the study.

    Measured: At the screening visit

  5. Variables associated with inadequate colon cleansing

    Collected through an anamnesis in a structured interview at the beginning of the study.

    Measured: At the screening visit

  6. Variables associated with neoplastic lesions

    Collected through an anamnesis in a structured interview at the beginning of the study.

    Measured: At the screening visit

  7. Adherence to colonoscopy preparation instructions

    Collected according to a validated questionnaire before the colonoscopy.

    Measured: Before the colonoscopy

  8. Tolerance and acceptability of the colonoscopy preparation

    Collected according to a validated questionnaire before the colonoscopy.

    Measured: Before the colonoscopy

  9. Variables on the lesions detected in the colonoscopy

    Collected through the colonoscopy report and the anatomopathological analysis of the lesions.

    Measured: At the time of colonoscopy

  10. Safety variables

    The adverse effects of the laxatives administered will be collected before the colonoscopy.

    Measured: Before the colonoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start6 Nov 2020
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomly assigned to 1 of 2 treatment groups with a 1:1 allocation using block sizes of 6 cases in each center.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598880
Sponsor's protocol ID
2020/9317
Status last verified
Oct 2020
First submitted
16 Oct 2020
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polyethylene glycol + ascorbate and Sodium picosulfate + magnesium citrate in people with Colonic Diseases, run by Parc de Salut Mar at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

High quality of entire colon cleansing according to the HS (time frame: At the time of colonoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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