NCT06597903

A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution

A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A first study at one centre, with a new oral gut cleansing solution, NRL994, in patients who were going to have a colonoscopy. The study was to find out how well the new "Low Dose Bowel Prep" (LDBP) worked, and whether it was safe to use.

Detailed description

A pilot monocentric, open phase I study to investigate the efficacy and safety of a new oral gut cleansing solution NRL994 in patients submitted to colonoscopy. The study was carried out as an open, uncontrolled investigation in a group of 36 in-patients scheduled for colonoscopy. Patients were enrolled one or two days prior to the endoscopic procedure. Gut cleansing started in the evening prior to the intervention when the first dose of LDBP was taken; bowel preparation was continued in the morning of the day of colonoscopy when the second dose was taken. A patient's participation in the study ended after completion of the endoscopic procedure. A dose of NRL994 was diluted in 1000 mL of water and consisted of 100 g PEG 3350, 7.5 g sodium sulphate, 4.7 g ascorbic acid, 5.9 g sodium ascorbate, 46 mmol sodium chloride, and 12.46 mmol potassium chloride. The product was flavoured with lemon flavour (2.015 g), anhydrous citric acid (1.565 g), and potassium acesulfame (0.35 g). Each dose of one litre had to be swallowed within one hour, followed by 500 mL of additional clear fluid.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	NRL994	In the afternoon/evening before colonoscopy: 1 litre solution plus 0.5 litre clear fluid. Day of colonoscopy: 1 litre solution plus at least up to 1 litre clear liquid.

Timeline

• Start date: 2001-05-01
• Primary completion: 2002-03-01
• Completion: 2002-03-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Germany