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

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ileus

Intervention: Alvimopan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cubist Pharmaceuticals Holdings LLC

Official(s) and/or principal investigator(s):
Adolor Corporation, Study Director, Affiliation: Cubist Pharmaceuticals Holdings LLC

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).

Clinical Details

Official title: A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: acceleration of gastrointestinal recovery

Secondary outcome:

time until ready for discharge 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

the prior 2 weeks

Locations and Contacts

Adolor Corporation, Exton, Pennsylvania 19341, United States
Additional Information

Adolor Corporation home web page address

Starting date: January 2002
Last updated: July 16, 2015

Page last updated: August 20, 2015

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