Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205842
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2005-09-13
Brief Title:
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel DysfunctionPostoperative Ileus
Sponsor:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
Cubist Pharmaceuticals LLC a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Phase IIIb Multicenter Double-Blind Placebo-Controlled Parallel Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel DysfunctionPostoperative Ileus
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus POI occurring in nearly all cases Signs and symptoms of POI may include abdominal distention and bloating persistent abdominal pain nausea andor vomiting variable reduction of bowel sounds delayed passage of or inability to pass flatus or stool and inability to tolerate a solid diet This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections
Detailed Description:
Postoperative ileus POI can be thought of as temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines Patients undergoing major abdominal surgery are at highest risk for developing POI occurring in nearly all cases Signs and symptoms of POI may include abdominal distention and bloating persistent abdominal pain nausea andor vomiting variable reduction of bowel sounds delayed passage of or inability to pass flatus or stool and inability to tolerate a solid diet This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14CL314 | OTHER | Sponsor protocol number | None |