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Alvimopan Use in Polytraumatized Patients

Primary Purpose

Post Operative Ileus

Status
Terminated
Phase
Phase 4
Locations
Puerto Rico
Study Type
Interventional
Intervention
Alvimopan
Placebo
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Ileus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18 to 80
  • Poly-traumatized patients
  • Extubated patients after abdominal exploration
  • Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen

Exclusion Criteria:

  • Mechanically ventilated patients
  • Patient not expected to survive Glasgow Coma Scale = 3
  • Pregnant patients
  • Apache score > 40 (observed mortality 100%) Saas Ahmed Naved et al 2011
  • Vasopressor therapy
  • Septic patients
  • Thoracotomy
  • Bogota bag
  • Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit
  • Patients with prior history of gastric surgery and/or colonic surgery
  • Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction
  • Prior pancreatic anastomosis or gastric anastomosis; ostomy formation
  • Chronic use of nonsteroidal anti-inflammatory drugs

Sites / Locations

  • Puerto Rico Trauma Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alvimopan

Placebo

Arm Description

Patients in the study group will be administered a post operative dose of Alvimopan

Patients in the Placebo group will receive a placebo pill and will be compared with the study group

Outcomes

Primary Outcome Measures

Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.
Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function

Secondary Outcome Measures

Length of stay in patients of the same population who receive a placebo.
Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual

Full Information

First Posted
February 17, 2017
Last Updated
January 31, 2020
Sponsor
University of Puerto Rico
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03068975
Brief Title
Alvimopan Use in Polytraumatized Patients
Official Title
A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated due to failure to enroll, a low volume of patients met criteria.
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Will create a double blind, randomized, parallel design study to evaluate the effectiveness of Alvimopan(post operative dose) in preventing post-operative ileus in poly-traumatized patients
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alvimopan
Arm Type
Experimental
Arm Description
Patients in the study group will be administered a post operative dose of Alvimopan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in the Placebo group will receive a placebo pill and will be compared with the study group
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo pill
Intervention Description
Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.
Primary Outcome Measure Information:
Title
Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.
Description
Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Length of stay in patients of the same population who receive a placebo.
Description
Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18 to 80 Poly-traumatized patients Extubated patients after abdominal exploration Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen Exclusion Criteria: Mechanically ventilated patients Patient not expected to survive Glasgow Coma Scale = 3 Pregnant patients Apache score > 40 (observed mortality 100%) Saas Ahmed Naved et al 2011 Vasopressor therapy Septic patients Thoracotomy Bogota bag Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit Patients with prior history of gastric surgery and/or colonic surgery Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction Prior pancreatic anastomosis or gastric anastomosis; ostomy formation Chronic use of nonsteroidal anti-inflammatory drugs
Facility Information:
Facility Name
Puerto Rico Trauma Hospital
City
San Juan
ZIP/Postal Code
00922
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
25819420
Citation
Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.
Results Reference
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Citation
Delaney CP, Weese JL, Hyman NH, Bauer J, Techner L, Gabriel K, Du W, Schmidt WK, Wallin BA; Alvimopan Postoperative Ileus Study Group. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005 Jun;48(6):1114-25; discussion 1125-6; author reply 1127-9. doi: 10.1007/s10350-005-0035-7.
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PubMed Identifier
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Citation
Delaney CP, Senagore AJ, Viscusi ER, Wolff BG, Fort J, Du W, Techner L, Wallin B. Postoperative upper and lower gastrointestinal recovery and gastrointestinal morbidity in patients undergoing bowel resection: pooled analysis of placebo data from 3 randomized controlled trials. Am J Surg. 2006 Mar;191(3):315-9. doi: 10.1016/j.amjsurg.2005.10.026.
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PubMed Identifier
26353904
Citation
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Results Reference
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PubMed Identifier
23171223
Citation
Hilton WM, Lotan Y, Parekh DJ, Basler JW, Svatek RS. Alvimopan for prevention of postoperative paralytic ileus in radical cystectomy patients: a cost-effectiveness analysis. BJU Int. 2013 Jun;111(7):1054-60. doi: 10.1111/j.1464-410X.2012.11499.x. Epub 2012 Nov 21.
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PubMed Identifier
16626607
Citation
Herzog TJ, Coleman RL, Guerrieri JP Jr, Gabriel K, Du W, Techner L, Fort JG, Wallin B. A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy. Am J Obstet Gynecol. 2006 Aug;195(2):445-53. doi: 10.1016/j.ajog.2006.01.039. Epub 2006 Apr 19.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Kalff JC, Schraut WH, Simmons RL, Bauer AJ. Surgical manipulation of the gut elicits an intestinal muscularis inflammatory response resulting in postsurgical ileus. Ann Surg. 1998 Nov;228(5):652-63. doi: 10.1097/00000658-199811000-00004.
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Alvimopan Use in Polytraumatized Patients

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