Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 11:06 AM
Study NCT ID:
NCT00597428
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2008-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Sponsor:
Sucampo Pharma Americas, LLC
Organization:
Study Overview
Official Title:
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
Status:
COMPLETED
Status Verified Date:
2015-11
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:
OPAL
Brief Summary:
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
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?: