Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597903
Status:
COMPLETED
Last Update Posted:
None
First Post:
2015-06-09
Brief Title:
A Monocentric Study to Investigate a New Low Dose Oral Gut Cleansing Solution
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 75 g sodium sulphate 47 g ascorbic acid 59 g sodium ascorbate 46 mmol sodium chloride and 1246 mmol potassium chloride The product was flavoured with lemon flavour 2015 g anhydrous citric acid 1565 g and potassium acesulfame 035 g
Each dose of one litre had to be swallowed within one hour followed by 500 mL of additional clear fluid
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 patients 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 75 g sodium sulphate 47 g ascorbic acid 59 g sodium ascorbate 46 mmol sodium chloride and 1246 mmol potassium chloride The product was flavoured with lemon flavour 2015 g anhydrous citric acid 1565 g and potassium acesulfame 035 g
Each dose of one litre had to be swallowed within one hour followed by 500 mL of additional clear fluid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None