NCT00388401

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2006

Completed
Last Updated

July 20, 2015

Status Verified

October 1, 2008

Enrollment Period

1.4 years

First QC Date

October 13, 2006

Last Update Submit

July 16, 2015

Conditions

Ileus

Keywords

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

  • acceleration of gastrointestinal recovery

Secondary Outcomes (7)

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

  • severity of GI symptoms

  • pain

  • opioid consumption

  • time to tolerate solid food

  • +2 more secondary outcomes

Interventions

AlvimopanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 the prior 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adolor Corporation

Exton, Pennsylvania, 19341, United States

Location

Related Publications (2)

  • 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. doi: 10.1097/01.sla.0000141158.27977.66.

    PMID: 15383800RESULT

  • 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: 20526599DERIVED

MeSH Terms

Conditions

Ileus

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive 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

Study Record Dates

First Submitted

October 13, 2006

First Posted

October 16, 2006

Study Start

January 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

July 20, 2015

Record last verified: 2008-10

Locations

US(1)