Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389233
Status:
COMPLETED
Last Update Posted:
2008-04-16
First Post:
2006-10-17
Brief Title:
A Phase III Trial to Assess the Efficacy Acceptability and Safety of Moviprep Versus a 4L PEGE Standard Solution
Sponsor:
Norgine
Organization:
Norgine
Study Overview
Official Title:
A Randomised Multi-Centre Single-Blinded Pivotal Phase III Trial to Assess the Efficacy Acceptability and Safety of a New 2 Litre Gut Cleansing Solution NRL994 Versus a Standard Colon Preparation With 4L PEGE
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 study was carried out as a randomised single-blind active-controlled multi-centric phase III study with two parallel treatment groups The primary efficacy criterion was the frequency of effective gut cleansing in each of the two treatment groups grade A or B overall quality of gut cleansing as judged by a blinded expert panel on the basis of videotapes recorded during the endoscopic procedure
Detailed Description:
The study was designed as a randomised active-controlled single-blind multi-centre pivotal phase III trial with two parallel treatment groups 15 German hospitals with specialised gastroenterology units were expected to participate in the investigation
Up to 360 hospital in-patients routinely scheduled to undergo complete colonoscopy were to be enrolled one to two days prior to the endoscopic procedure and to be randomly allocated to one of the two treatment arms in a ratio of 11 Bowel preparation was performed using equal split doses of either low-volume NRL994 two doses of 1000 mL each or high-volume PEGE two doses of 2000 mL each The first dose was to be taken in the evening before the procedure the second dose on the morning of the day of the colonoscopy The patients allocated to NRL994 were asked to drink at least 1L of additional clear liquid in addition to the study drug During colonoscopy the cleansing of each of the five pre-defined gut segments was to be assessed by the physician performing the examination using a 5-level verbal rating scale Videotapes were to be recorded of all procedures in order to allow central review by a blinded and independent expert panel whose ratings were the primary basis for the analysis of efficacy The patients enrolled in the study were asked to fill in a questionnaire concerning the acceptability of the preparation A patients participation in the study was terminated upon completion of the intervention by performing a final examination and filling in the study termination page No interim analysis was to be performed
Up to 360 hospital in-patients routinely scheduled to undergo complete colonoscopy were to be enrolled one to two days prior to the endoscopic procedure and to be randomly allocated to one of the two treatment arms in a ratio of 11 Bowel preparation was performed using equal split doses of either low-volume NRL994 two doses of 1000 mL each or high-volume PEGE two doses of 2000 mL each The first dose was to be taken in the evening before the procedure the second dose on the morning of the day of the colonoscopy The patients allocated to NRL994 were asked to drink at least 1L of additional clear liquid in addition to the study drug During colonoscopy the cleansing of each of the five pre-defined gut segments was to be assessed by the physician performing the examination using a 5-level verbal rating scale Videotapes were to be recorded of all procedures in order to allow central review by a blinded and independent expert panel whose ratings were the primary basis for the analysis of efficacy The patients enrolled in the study were asked to fill in a questionnaire concerning the acceptability of the preparation A patients participation in the study was terminated upon completion of the intervention by performing a final examination and filling in the study termination page No interim analysis was to be 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