NCT05174845

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

An Observational, Retrospective and Multicenter Study to Evaluate the Effectiveness and Safety of 1L (PEG)+ Ascorbic Acid Given for Bowel Preparation Prior to Colonoscopy in Iberia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13,393 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data). The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.

Conditions

• Colon Cancer
• Colon Disease
• Colon Cleansing

Interventions

Type	Name	Description
DRUG	1L PEG + ASCORBIC ACID	* 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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2022-01-03
• Last updated: 2022-05-31

Locations

12 sites across 2 countries: Portugal, Spain

Regulatory

• FDA-regulated drug study