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Alvimopan Use in Polytraumatized Patients

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ClinicalTrials.gov Identifier: NCT03068975
Recruitment Status : Terminated (This study was terminated due to failure to enroll, a low volume of patients met criteria.)
First Posted : March 3, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pablo Rodriguez Ortiz, University of Puerto Rico

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.

Condition or disease Intervention/treatment Phase
Post Operative Ileus Drug: Alvimopan Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : November 19, 2019
Actual Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Alvimopan

Arm Intervention/treatment
Experimental: Alvimopan
Patients in the study group will be administered a post operative dose of Alvimopan
Drug: Alvimopan
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.
Other Name: Entereg

Placebo Comparator: Placebo
Patients in the Placebo group will receive a placebo pill and will be compared with the study group
Drug: Placebo
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.
Other Name: placebo pill




Primary Outcome Measures :
  1. Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo. [ Time Frame: 2 years ]
    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 :
  1. Length of stay in patients of the same population who receive a placebo. [ Time Frame: 5 years ]
    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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068975


Locations
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Puerto Rico
Puerto Rico Trauma Hospital
San Juan, Puerto Rico, 00922
Sponsors and Collaborators
University of Puerto Rico
Merck Sharp & Dohme Corp.
Publications:

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Responsible Party: Pablo Rodriguez Ortiz, MD, University of Puerto Rico
ClinicalTrials.gov Identifier: NCT03068975    
Other Study ID Numbers: 55238
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alvimopan
Gastrointestinal Agents