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

Ileus Clinical Trial

Official title:

A Phase IIIb, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205842
• Other study ID #: 3753-001
• Secondary ID: 14CL314
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 7, 2016
• Start date: June 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2016
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.

Description:

Postoperative ileus (POI) can be thought of as temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. Patients undergoing major abdominal surgery are at highest risk for developing POI, occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start of surgery to hasten the recovery of GI function in patients having partial small or large bowel resections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• 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 with primary anastomosis; all procedures must be performed completely by open 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, any laparoscopic or laparoscopically-assisted procedure, or subject has a history of gastrectomy, total colectomy, short bowel syndrome, or multiple previous abdominal surgeries performed by open laparotomy.

• Subject has complete bowel obstruction.

• Subject is currently taking opioid analgesics or has taken more than three doses of opioids (oral or parenteral) within the previous 7 days prior to the day of surgery.

Study Design

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

Related Conditions & MeSH terms

• Ileus
• Intestinal Diseases

Intervention

Drug:
• alvimopan

Locations

Country	Name	City	State
United States	50 Sites	Exton	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ludwig K, Enker WE, Delaney CP, Wolff BG, Du W, Fort JG, Cherubini M, Cucinotta J, Techner L. Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated po — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery of GI function, which will be the time to Recovery of both upper GI function (tolerating solid food), and lower GI recovery (first bowel movement). Referred to as GI2.
Secondary	Time to discharge order written, time to actual discharge, time to tolerate solid food and time to first bowel movement