Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388258
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2006-10-13
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 Multicenter Phase III Double-Blind Placebo-Controlled Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel DysfunctionPostoperative Ileus
Status:
COMPLETED
Status Verified Date:
2017-08
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 bloating persistent abdominal pain nausea andor vomiting delayed passage or inability to pass flatus or stool and inability to tolerate a solid diet This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery bowel resection or abdominal hysterectomy
Detailed Description:
Postoperative ileus POI is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines This functional impairment persists for a variable duration following surgery usually resolving within 1 day in the small intestine 1 to 3 days in the stomach and 3 to 5 days in the colon When POI persists for more than 5 days it is generally considered severe sometimes referred to as complicated or prolonged POI and increases the risk for related morbidity No drug therapy has been shown to consistently shorten the duration of POI This study is designed to demonstrate that alvimopan a novel peripherally acting mu opioid receptor antagonist accelerates the recovery of GI function in patients undergoing bowel resection of hysterectomy
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 |
|---|---|---|---|
| 14CL302 | OTHER | Cubist Study Number | None |