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

Primary Purpose

Ileus

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

alvimopan

About this trial

This is an interventional treatment trial for Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

50 Sites

Outcomes

Primary Outcome Measures

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 Outcome Measures

Time to discharge order written, time to actual discharge, time to tolerate solid food and time to first bowel movement

Full Information

NCT ID

NCT00205842

First Posted

September 13, 2005

Last Updated

January 7, 2016

Sponsor

Cubist Pharmaceuticals LLC

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00205842

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cubist Pharmaceuticals LLC

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. 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 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ileus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

660 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

alvimopan

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Time to discharge order written, time to actual discharge, time to tolerate solid food and time to first bowel movement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adolor Corporation

Organizational Affiliation

Cubist Pharmaceuticals LLC

Official's Role

Study Director

Facility Information:

Facility Name

50 Sites

City

Exton

State/Province

Pennsylvania

ZIP/Postal Code

19341

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19015469

Citation

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 postoperative care pathway. Arch Surg. 2008 Nov;143(11):1098-105. doi: 10.1001/archsurg.143.11.1098.

Results Reference

result

PubMed Identifier

20526599

Citation

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.

Results Reference

derived

Learn more about this trial

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

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