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

ID: NCT00388258
Status: Completed
Phase: Phase 3
Start Date: March 01, 2001
First Submitted: October 13, 2006
Last Updated: August 17, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: United States
Conditions: Ileus
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Study Description

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.
Condition or disease Intervention/treatment Phase

Ileus

Drug: Alvimopan
Other Names
Phase 3

Tracking Information

First Submitted DateOctober 13, 2006
Last Update Posted DateAugust 17, 2017
Actual Start DateMarch 01, 2001
Actual Completion DateDecember 01, 2002
Actual Primary Completion DateDecember 01, 2002
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • acceleration of gastrointestinal recovery

Original Primary Outcome Measures

Not Available

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

Not Available

Study Design

Brief TitleStudy of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Official TitleA 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 TypeInterventional
Study PhasePhase 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 MethodN/A
Study PopulationN/A
Intervention
Drug: Alvimopan

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment451
Completion DateDecember 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00388258
Other Study ID Numbers
3753-015
14CL302
Has Data Monitoring CommitteeNo
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