Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322062
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2006-05-02
Brief Title:
MOVIPREP Versus NaP Pivotal Phase III Study
Sponsor:
Norgine
Organization:
Norgine
Study Overview
Official Title:
A Prospective Randomised Single-Blinded Multicentric and Pivotal Phase III Study Comparing the Efficacy Safety and Acceptability of a New 2 Litres Gut Lavage Solution NRL994 Versus a Sodium Phosphate Solution for Colonoscopy Preparation
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market Efficacy of each bowel preparation safety and acceptability will be assessed
Detailed Description:
Multicentric 15 centres prospective randomised single-blinded phase III pivotal study in patients undergoing a colonoscopy Gut cleansing will be performed using 2 litres of NRL994 gut lavage solution with 1 litre or more of extra clear liquids or 2 x 45 ml of a sodium phosphate solution plus 2 litres or more of extra clear liquids the day before colonoscopy Patients requiring a morning colonoscopy who fulfil the inclusion criteria will be randomised One of the two tested products will be delivered by a pharmacist blindly from the gastroenterologist The assigned product will be taken the day before the coloscopy according to the information leaflet Efficacy of the two tested preparations will be measured on video-tape record of each colonoscopy by a final grading ie the overall quality of colonoscopy prep by an gastroenterologist expert A standardised patient questionnaire administered by a nurse on the morning before colonoscopy will assess clinical tolerance and acceptability satisfaction of the prep A baseline blood sampling will be withdrew before intake of the preparation and one more blood sample will be performed after the intake on the morning before the coloscopy
After the coloscopy as the gastroenterologist gives the result of the coloscopy a last visit is performed
After the coloscopy as the gastroenterologist gives the result of the coloscopy a last visit is performed
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