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

NCT00388258 | Completed Phase 3

• 2 other identifiers: 3753-01514CL302
• Study Type: interventional
• Target: 451
• 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, 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

Keywords

Postoperative ileus

Outcome Measures

Primary Outcomes (1)

• acceleration of gastrointestinal recovery

Secondary Outcomes (7)

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

• severity of GI symptoms

• pain

• opioid consumption

• time to tolerate solid food

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 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

You may not qualify if:

• 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

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)

• 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 abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. doi: 10.1007/s10350-005-0035-7.

  PMID: 15906123 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 16, 2006
• Study Start: March 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

US (1)