Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia

NCT05174845 | Completed FDA Drug

• 1 other identifier: PLEN-01/2021
• Study Type: observational
• Target: 13,393
• Locations: 2 countries
• Sites: 12

Brief Summary

A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.

Conditions

Colon Cancer; Colon Disease; Colon Cleansing

Outcome Measures

Primary Outcomes (2)

• Number of patients With Successful Bowel Cleansing (Overall Colon)

  The proportion of patients with adequate total colon cleansing is defined as a Boston Bowel preparation scale (BBPS) score ≥ 2 in all segments (BBPS\> 6).

  Up to 2 days (from day of first dosing to day of colonoscopy)

• Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)

  Proportion of patients with a high-quality cleaning in the right colon defined as a BBPS score = 3.

  Up to 2 days (from day of first dosing to day of colonoscopy)

Secondary Outcomes (13)

• Polyps Detection Rate in the total colon and in the right colon

  Up to 2 days (from day of first dosing to day of colonoscopy)

• Adenoma Detection Rate in the total colon and in the right colon

  Up to 2 days (from day of first dosing to day of colonoscopy)

• Cecal intubation rate

  Up to 2 days (from day of first dosing to day of colonoscopy)

• Cecal intubation time

  Up to 2 days (from day of first dosing to day of colonoscopy)

• Withdrawal time

  Up to 2 days (from day of first dosing to day of colonoscopy)

Interventions

1L PEG + ASCORBIC ACID DRUG

* 2-Day Split-Dosing: The patient has taken the product in the evening before the scheduled colonoscopy and mandatory additional clear fluid. The patient has taken the second dose with mandatory additional clear fluids on the morning of the colonoscopy. * Same Day: The patient has taken the first dose of the product on the day of the colonoscopy and take mandatory additional clear fluid. After a 1-2 hour break, the patient has taken a second dose plus additional clear mandatory fluid.

Also known as: PLENVU, NER1006, PLEINVUE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy who have prepared with NER1006

You may qualify if:

• Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
• Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.

You may not qualify if:

• History of colorectal cancer o colectomy before the first colonoscopy
• Impossibility to obtain the required mandatory data

Sponsors & Collaborators

• Norgine: lead
• Xolomon Tree S.L.: collaborator

Study Sites (12)

Hospital da Senhora da Oliveira

Guimarães, Portugal

Location

Hospital CUF Descobertas

Lisbon, Portugal

Location

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Location

Hospital San Rafael

A Coruña, Spain

Location

HM Sant Jordi

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Doctor López Cano

Cadiz, Spain

Location

Complejo hospitalario Ruber Juan Bravo

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital La Zarzuela

Madrid, Spain

Location

Hospital Quirón salud Sagrado Corazón

Seville, Spain

Location

Consorcio Hospitalario Provincial de Castelló

Valencia, Spain

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Diseases

Interventions

Ascorbic Acid; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Ethylene Glycols; Glycols; Alcohols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jose Miguel Esteban López-Jamar, MD

  Norgine Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

PT (2); ES (10)