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

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ClinicalTrials.gov Identifier: NCT04598880
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar

Study Description
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Brief 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®).


Condition or disease Intervention/treatment Phase
Colonic Diseases Drug: Polyethylene glycol + ascorbate Drug: Sodium picosulfate + magnesium citrate Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description: The assignment of each treatment will be displayed at the time of patient enrollment and will be open to the participant and the physician. The investigator who performs the colonoscopy and assesses the primary outcome (digestive endoscopist) is blinded.
Primary Purpose: Treatment
Official Title: Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. High quality of entire colon cleansing according to the HS [ Time Frame: At the time of colonoscopy ]
    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.


Secondary Outcome Measures :
  1. High quality of segmental colon cleansing according to the HS [ Time Frame: At the time of colonoscopy ]
    High quality cleansing in each segment of colon (segmental) according to the HS, which is defined as a score of 3 or 4 points.

  2. Successful global and segmental colon cleansing according to the HS [ Time Frame: At the time of colonoscopy ]
    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.

  3. High quality and adequate quality of global and segmental colon cleansing according to the BBPS [ Time Frame: At the time of colonoscopy ]

    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.


  4. Demographic variables [ Time Frame: At the screening visit ]
    Collected through an anamnesis in a structured interview at the beginning of the study.

  5. Variables associated with inadequate colon cleansing [ Time Frame: At the screening visit ]
    Collected through an anamnesis in a structured interview at the beginning of the study.

  6. Variables associated with neoplastic lesions [ Time Frame: At the screening visit ]
    Collected through an anamnesis in a structured interview at the beginning of the study.

  7. Adherence to colonoscopy preparation instructions [ Time Frame: Before the colonoscopy ]
    Collected according to a validated questionnaire before the colonoscopy.

  8. Tolerance and acceptability of the colonoscopy preparation [ Time Frame: Before the colonoscopy ]
    Collected according to a validated questionnaire before the colonoscopy.

  9. Variables on the lesions detected in the colonoscopy [ Time Frame: At the time of colonoscopy ]
    Collected through the colonoscopy report and the anatomopathological analysis of the lesions.

  10. Safety variables [ Time Frame: Before the colonoscopy ]
    The adverse effects of the laxatives administered will be collected before the colonoscopy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598880


Contacts
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Contact: Marco Antonio Alvarez González, MD, PhD +34932483057 MAAlvarez@parcdesalutmar.cat

Locations
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Spain
Hospital de Viladecans Not yet recruiting
Viladecans, Barcelona, Spain
Contact: Ana García Rodríguez    +34936590111    anagrod4@gmail.com   
Sub-Investigator: Ana García Rodríguez         
Organización Sanitaria Integrada Araba Not yet recruiting
Alava, Spain
Contact: Aitor Oribe    +34945007000    aitor_orive@yahoo.com   
Sub-Investigator: Aitor Oribe         
Hospital de Poniente Not yet recruiting
Almería, Spain
Contact: Francisco Gallego Rojo    +34950022942    fgallegorojo@gmail.com   
Sub-Investigator: Francisco Gallego Rojo         
Hospital Germans Trias i Pujol Not yet recruiting
Badalona, Spain
Contact: Ingrid Marín Fernández    +34934978800    gridin_8@hotmail.com   
Sub-Investigator: Ingrid Marín Fernández         
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Marco Antonio Alvarez González, MD, PhD    +34932483057    MAAlvarez@parcdesalutmar.cat   
Principal Investigator: Marco Antonio Alvarez González, MD, PhD         
Hospital Virgen de las Nieves Not yet recruiting
Granada, Spain
Contact: Eduardo Redondo Cerezo    +34958020146    eredondoc@yahoo.es   
Sub-Investigator: Eduardo Redondo Cerezo         
Clínica Universidad de Navarra Not yet recruiting
Madrid, Spain
Contact: Jose María Riesco    +34913531920    cucoriesco@hotmail.com   
Sub-Investigator: Jose María Riesco         
Hospital de la Princesa Not yet recruiting
Madrid, Spain
Contact: Pablo Miranda    +34915202250    pmpablomiranda@gmail.com   
Sub-Investigator: Pablo Miranda         
Hospital Gregorio Marañón Not yet recruiting
Madrid, Spain
Contact: Oscar Nogales Rincón    +34915868307    oscarnogalesrincon@gmail.com   
Sub-Investigator: Oscar Nogales Rincón         
Hospital La Paz Not yet recruiting
Madrid, Spain
Contact: Pedro de María Pallarés    +34917277000    pedro.demaria@gmail.com   
Sub-Investigator: Pedro de María Pallarés         
Hospital Ramón y Cajal Not yet recruiting
Madrid, Spain
Contact: Enrique Rodríguez de Santiago    +34913368772    e_rodriguez_de_santiago@hotmail.com   
Sub-Investigator: Enrique Rodríguez de Santiago         
Hospital Costa del Sol Not yet recruiting
Marbella, Spain
Contact: Andrés Sánchez Yague    +34951976669    asyague@gmail.com   
Sub-Investigator: Andrés Sánchez Yague         
Hospital Quirón Not yet recruiting
Málaga, Spain
Contact: Pedro Rosón    +34951940000    pjroson@gmail.com   
Sub-Investigator: Pedro Rosón         
Hospital Santa Bárbara Not yet recruiting
Soria, Spain
Contact: Santiago Frago Larramona    +34975234300    santifrago@gmail.com   
Sub-Investigator: Santiago Frago Larramona         
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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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)
More Information
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04598880    
Other Study ID Numbers: 2020/9317
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
Colonoscopy
Additional relevant MeSH terms:
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Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Picosulfate sodium
Magnesium citrate
Cathartics
Gastrointestinal Agents