Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310765
Status:
TERMINATED
Last Update Posted:
2023-10-23
First Post:
2006-03-31
Brief Title:
Pregabalin for Abdominal Pain From Adhesions
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Pregabalin for the Treatment of Abdominal Pain From Adhesions Placebo Controlled Trial
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated by the sponsor due to low accrual
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 if pregabalin demonstrates significant reduction in abdominal pain from adhesions
Detailed Description:
The study will be prospective double-blinded and randomized The study will run for 12 weeks During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug During the last 4 weeks of the study all subjects will be offered the study medication pregabalin The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption
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