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

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®).

Study Overview

• Status: Unknown
• Conditions: Colonic Diseases
• Intervention / Treatment: Drug: Polyethylene glycol + ascorbate; Drug: Sodium picosulfate + magnesium citrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1104
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Marco Antonio Alvarez González, MD, PhD; Phone Number: +34932483057; Email: MAAlvarez@parcdesalutmar.cat

Study Locations

• Spain
  • Alava, Spain
    • Not yet recruiting
    • Organización Sanitaria Integrada Araba
    • Contact: Aitor Oribe; Phone Number: +34945007000; Email: aitor_orive@yahoo.com
    • Sub-Investigator: Aitor Oribe
  • Almería, Spain
    • Not yet recruiting
    • Hospital de Poniente
    • Contact: Francisco Gallego Rojo; Phone Number: +34950022942; Email: fgallegorojo@gmail.com
    • Sub-Investigator: Francisco Gallego Rojo
  • Badalona, Spain
    • Not yet recruiting
    • Hospital Germans Trias i Pujol
    • Contact: Ingrid Marín Fernández; Phone Number: +34934978800; Email: gridin_8@hotmail.com
    • Sub-Investigator: Ingrid Marín Fernández
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital Del Mar
    • Contact: Marco Antonio Alvarez González, MD, PhD; Phone Number: +34932483057; Email: MAAlvarez@parcdesalutmar.cat
    • Principal Investigator: Marco Antonio Alvarez González, MD, PhD
  • Granada, Spain
    • Not yet recruiting
    • Hospital Virgen de las Nieves
    • Contact: Eduardo Redondo Cerezo; Phone Number: +34958020146; Email: eredondoc@yahoo.es
    • Sub-Investigator: Eduardo Redondo Cerezo
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Ramón y Cajal
    • Contact: Enrique Rodríguez de Santiago; Phone Number: +34913368772; Email: e_rodriguez_de_santiago@hotmail.com
    • Sub-Investigator: Enrique Rodríguez de Santiago
  • Madrid, Spain
    • Not yet recruiting
    • Hospital La Paz
    • Contact: Pedro de María Pallarés; Phone Number: +34917277000; Email: pedro.demaria@gmail.com
    • Sub-Investigator: Pedro de María Pallarés
  • Madrid, Spain
    • Not yet recruiting
    • Clinica Universidad de Navarra
    • Contact: Jose María Riesco; Phone Number: +34913531920; Email: cucoriesco@hotmail.com
    • Sub-Investigator: Jose María Riesco
  • Madrid, Spain
    • Not yet recruiting
    • Hospital de La Princesa
    • Contact: Pablo Miranda; Phone Number: +34915202250; Email: pmpablomiranda@gmail.com
    • Sub-Investigator: Pablo Miranda
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Gregorio Marañón
    • Contact: Oscar Nogales Rincón; Phone Number: +34915868307; Email: oscarnogalesrincon@gmail.com
    • Sub-Investigator: Oscar Nogales Rincón
  • Marbella, Spain
    • Not yet recruiting
    • Hospital Costa del Sol
    • Contact: Andrés Sánchez Yague; Phone Number: +34951976669; Email: asyague@gmail.com
    • Sub-Investigator: Andrés Sánchez Yague
  • Málaga, Spain
    • Not yet recruiting
    • Hospital Quirón
    • Contact: Pedro Rosón; Phone Number: +34951940000; Email: pjroson@gmail.com
    • Sub-Investigator: Pedro Rosón
  • Soria, Spain
    • Not yet recruiting
    • Hospital Santa Bárbara
    • Contact: Santiago Frago Larramona; Phone Number: +34975234300; Email: santifrago@gmail.com
    • Sub-Investigator: Santiago Frago Larramona
  • Barcelona
    • Viladecans, Barcelona, Spain
      • Not yet recruiting
      • Hospital de Viladecans
      • Contact: Ana García Rodríguez; Phone Number: +34936590111; Email: anagrod4@gmail.com
      • Sub-Investigator: Ana García Rodríguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Pregnancy or lactation
• Inability to understand the instructions by language barrier or cognitive disorder
• Refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pleinvue; Subjects receive polyethylene glycol + ascorbate (PEG1A) as laxative treatment for colonoscopy preparation.	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).; Other Names: Pleinvue®; PEG1A
Experimental: Citrafleet; Subjects receive sodium picosulfate + magnesium citrate (PSCM) as laxative treatment for colonoscopy preparation.	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.; Other Names: Citrafleet®; PSCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At the time of colonoscopy
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.	At the time of colonoscopy
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.	At the time of colonoscopy
Demographic variables	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Variables associated with inadequate colon cleansing	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Variables associated with neoplastic lesions	Collected through an anamnesis in a structured interview at the beginning of the study.	At the screening visit
Adherence to colonoscopy preparation instructions	Collected according to a validated questionnaire before the colonoscopy.	Before the colonoscopy
Tolerance and acceptability of the colonoscopy preparation	Collected according to a validated questionnaire before the colonoscopy.	Before the colonoscopy
Variables on the lesions detected in the colonoscopy	Collected through the colonoscopy report and the anatomopathological analysis of the lesions.	At the time of colonoscopy
Safety variables	The adverse effects of the laxatives administered will be collected before the colonoscopy.	Before the colonoscopy

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Investigators: Principal Investigator: Marco Antonio Alvarez González, MD, PhD, Hospital del Mar (Barcelona, Spain); Principal Investigator: Eduardo Albéniz, MD, PhD, Complejo Hospitalario de Navarra (Pamplona, Spain)

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases; Gastrointestinal Agents; Cathartics; Picosulfate sodium; Magnesium citrate
• Other Study ID Numbers: 2020/9317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No