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

NCT00388479 | Completed Phase 3

• 1 other identifier: 14CL308
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Ileus

Outcome Measures

Primary Outcomes (1)

• Acceleration of gastrointestinal recovery

Secondary Outcomes (7)

• Time until ready for discharge based upon recovery of GI function

• Severity of GI symptoms

• Pain

• Opioid Consumption

• Time to tolerate liquids

Interventions

Alvimopan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Various

Exton, Pennsylvania, 19341, United States

Location

Related Publications (2)

• Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7.

  PMID: 16333556 RESULT

• Ludwig K, Viscusi ER, Wolff BG, Delaney CP, Senagore A, Techner L. Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis. World J Surg. 2010 Sep;34(9):2185-90. doi: 10.1007/s00268-010-0635-9.

  PMID: 20526599 DERIVED

MeSH Terms

Conditions

Ileus

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Adolor Corporation

  Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 16, 2006
• Study Start: December 1, 2001
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: July 20, 2015

Record last verified: 2015-07

Locations

US (1)