Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759885
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2020-11-30
Brief Title:
Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep
Sponsor:
NTC srl
Organization:
NTC srl
Study Overview
Official Title:
Efficacy and Safety of mAnniTol in Bowel Preparation Assessment of Adequacy and Presence of Intestinal levelS of Hydrogen and Methane During Elective Colonoscopy aFter mAnnitol or Standard Split 2-liter Polyethylene Glycol Solution Plus asCorbaTe - a Phase IIIII International Multicentre Randomized Parallel-group endoscOpist-bliNded Dose-findingNon-inferiority Study - SATISFACTION
Status:
COMPLETED
Status Verified Date:
2022-07
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:
SATISFACTION
Brief Summary:
The purpose of this dose findingcomparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation phase II and subsequently demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC Moviprep phase III in bowel preparation for colonoscopy
Detailed Description:
Study Start and Study Completion dates relative to the Phase IIIII are reported here
Phase II Patients n 183
Date of first enrolment 22 June 2020
Date LPLV 12 November 2020
Phase III Patients n 703
Date of first enrolment 2 March 2021
Date LPLV 16 July 2021
Date on which the study was entered in the EudraCT database 13 October 2020
Phase II Patients n 183
Date of first enrolment 22 June 2020
Date LPLV 12 November 2020
Phase III Patients n 703
Date of first enrolment 2 March 2021
Date LPLV 16 July 2021
Date on which the study was entered in the EudraCT database 13 October 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002856-18 | EUDRACT_NUMBER | None | None |