Ileus Clinical Trial
Official title:
A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
Verified date | August 2017 |
Source | Cubist Pharmaceuticals LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 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).
Status | Completed |
Enrollment | 451 |
Est. completion date | December 1, 2002 |
Est. primary completion date | December 1, 2002 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is scheduled for a partial small/large bowel resection of 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 is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery |
Country | Name | City | State |
---|---|---|---|
United States | Various | Exton | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Cubist Pharmaceuticals LLC | GlaxoSmithKline |
United States,
Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major ab — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | acceleration of gastrointestinal recovery | |||
Secondary | time until ready for discharged based upon recovery of GI function | |||
Secondary | severity of GI symptoms | |||
Secondary | pain | |||
Secondary | opioid consumption | |||
Secondary | time to tolerate solid food | |||
Secondary | need for reinsertion of nasogastric tube | |||
Secondary | time until discharge order is written |
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