Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2001 |
| End Date: | November 2003 |
A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
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 and/or 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).
ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal
distention and bloating, persistent abdominal pain; nausea and/or 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).
Postoperative ileus (POI) is a 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 or hysterectomy.
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 or hysterectomy.
Inclusion Criteria:
- Subject is scheduled for a partial small/large bowel resection with primary
anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
- Subject is scheduled to receive primary postoperative pain management with
intravenous (i.v.) patient-controlled analgesia (PCA) opioids
Exclusion Criteria:
- Subject is scheduled for a total colectomy, colostomy, ileostomy
- Subject has complete bowel obstruction
- Subject has recently been on an acute course (1-10 days) of opioid analgesics and has
not been off all opioids for at least 1 week prior to surgery Subject has been on
chronic (>10 days) opioid analgesics and has not been off all opioids for at least 2
weeks prior to surgery.
We found this trial at
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