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

Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388401
• Other study ID #: 14CL313
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2006
• Last updated: July 16, 2015
• Start date: January 2002
• Est. completion date: June 2003

Study information

• Verified date: October 2008
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ileus
• Intestinal Diseases

Intervention

Drug:
• Alvimopan

Locations

Country	Name	City	State
United States	Adolor Corporation	Exton	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wolff BG, Michelassi F, Gerkin TM, Techner L, Gabriel K, Du W, Wallin BA; Alvimopan Postoperative Ileus Study Group. Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acceleration of gastrointestinal recovery
Secondary	time until ready for discharge based upon recovery of GI function
Secondary	severity of GI symptoms
Secondary	pain
Secondary	opioid consumption
Secondary	time to tolerate solid food
Secondary	need for reinsertion of nasogastric tube
Secondary	time until discharge order is written