Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 6:06 PM
Study NCT ID:
NCT02292459
Status:
WITHDRAWN
Last Update Posted:
2015-07-16
First Post:
2014-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Multicenter, Open Label, Non-controlled Phase 3 Clinical Trial of the Efficacy and the Safety for the Relief of Constipation of Polyethylene Glycol 3350
Status:
WITHDRAWN
Status Verified Date:
2015-07
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:
None
Brief Summary:
The purpose of this study is to evaluate the complete resolution of constipation in participants taking PEG 3350 compared to those taking PEG 4000, based on analysis of the number of bowel movements from self-reported bowel movement (BM) data. The complete resolution of constipation is defined as the elimination of straining or of hard/lumpy stools.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: