Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Ileus	Drug: Alvimopan Other Names	Phase 3

Tracking Information

First Submitted Date	October 13, 2006
Last Update Posted Date	August 17, 2017
Actual Start Date	March 01, 2001
Actual Completion Date	December 01, 2002
Actual Primary Completion Date	December 01, 2002
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• acceleration of gastrointestinal recovery

Original Primary Outcome Measures

Current Secondary Outcome Measures

• time until ready for discharged based upon recovery of GI function

• severity of GI symptoms

• pain

• opioid consumption

• time to tolerate solid food

• need for reinsertion of nasogastric tube

• time until discharge order is written

Original Secondary Outcome Measures

Study Design

Brief Title	Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Official Title	A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
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 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).
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 Type	Interventional
Study Phase	Phase 3
Estimated Enrollment	451
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Conditions	Ileus
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: Alvimopan Other Names
Study Groups/Cohorts	Not Available
Study Arms	Not Available

Arm	Intervention/Treatment

Recruitment Information

Recruitment Status:	Completed
Enrollment	451
Completion Date	December 01, 2002
Eligibility Criteria:	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
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	United States

Administrative Information

NCT Number:	NCT00388258
Other Study ID Numbers	3753-015 14CL302
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Cubist Pharmaceuticals LLC
Collaborators	GlaxoSmithKline
Investigators	Study Director Adolor Corporation Cubist Pharmaceuticals LLC