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

• ClinicalTrials.gov Identifier: NCT00388401
• Recruitment Status: Completed
• First Posted: October 16, 2006
• Last Update Posted: July 20, 2015
• Sponsor: Cubist Pharmaceuticals LLC
• Collaborator: GlaxoSmithKline
• Information provided by: Cubist Pharmaceuticals LLC

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).

Condition or disease	Intervention/treatment	Phase
Ileus	Drug: Alvimopan	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: January 2002
• Actual Primary Completion Date: June 2003
• Actual Study Completion Date: June 2003

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. acceleration of gastrointestinal recovery

Secondary Outcome Measures :

1. time until ready for discharge based upon recovery of GI function
2. severity of GI symptoms
3. pain
4. opioid consumption
5. time to tolerate solid food
6. need for reinsertion of nasogastric tube
7. time until discharge order is written

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Adolor Corporation

Exton, Pennsylvania, United States, 19341

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

GlaxoSmithKline

Investigators

• Study Director: Adolor Corporation; Cubist Pharmaceuticals LLC

More Information

Publications of Results:

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, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004 Oct;240(4):728-34; discussion 734-5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00388401
• Other Study ID Numbers: 14CL313
• First Posted: October 16, 2006
• Last Update Posted: July 20, 2015
• Last Verified: October 2008

Keywords provided by Cubist Pharmaceuticals LLC:

Postoperative Ileus

Additional relevant MeSH terms:

Ileus; Intestinal Diseases; Intestinal Obstruction; Gastrointestinal Diseases; Digestive System Diseases; Alvimopan; Gastrointestinal Agents