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Post Operative IleusPhase 4NCT03068975

Alvimopan Use in Polytraumatized Patients

A Phase 4 study testing Alvimopan in people with Post Operative Ileus, run by University of Puerto Rico at 1 site in Puerto Rico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Post Operative Ileus
What is being tested?
Alvimopan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
1 sitePuerto Rico
Study dates
1 Sep 2017to 19 Nov 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Puerto Rico1 site

  • Puerto Rico Trauma Hospital

    San Juan, US, 00922

Other trials in Puerto Rico

About this study

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

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.

Being tested
Alvimopan, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlvimopanDrug

    Also called Entereg

    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.

  • PlaceboDrug

    Also called placebo pill

    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.

Study groups in NCT03068975
Study groupRoleWhat they receive
AlvimopanExperimentalPatients in the study group will be administered a post operative dose of Alvimopan
Receives: Drug: Alvimopan
PlaceboPlacebo comparatorPatients in the Placebo group will receive a placebo pill and will be compared with the study group
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (1)

  1. 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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start1 Sep 2017
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Why it stopped: This study was terminated due to failure to enroll, a low volume of patients met criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03068975
Sponsor's protocol ID
55238
Status last verified
Jan 2020
First submitted
17 Feb 2017
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 25819420

  • 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.

    PubMed 15906123

  • 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.

    PubMed 16490538

  • Earnshaw SR, Kauf TL, McDade C, Potashman MH, Pauyo C, Reese ES, Senagore A. Economic Impact of Alvimopan Considering Varying Definitions of Postoperative Ileus. J Am Coll Surg. 2015 Nov;221(5):941-50. doi: 10.1016/j.jamcollsurg.2015.08.004. Epub 2015 Aug 15.

    PubMed 26353904

  • 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.

    PubMed 23171223

  • 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.

    PubMed 16626607

  • Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.

    PubMed 11091234

  • 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.

    PubMed 9833803

  • 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.

    PubMed 20526599

  • 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.

    PubMed 19015469

  • Manger JP, Nelson M, Blanchard S, Helo S, Conaway M, Krupski TL. Alvimopan: A cost-effective tool to decrease cystectomy length of stay. Cent European J Urol. 2014;67(4):335-41. doi: 10.5173/ceju.2014.04.art4. Epub 2014 Dec 5.

    PubMed 25667750

  • Miedema BW, Johnson JO. Methods for decreasing postoperative gut dysmotility. Lancet Oncol. 2003 Jun;4(6):365-72. doi: 10.1016/s1470-2045(03)01118-5.

    PubMed 12788410

  • Naved SA, Siddiqui S, Khan FH. APACHE-II score correlation with mortality and length of stay in an intensive care unit. J Coll Physicians Surg Pak. 2011 Jan;21(1):4-8.

    PubMed 21276376

  • Simorov A, Thompson J, Oleynikov D. Alvimopan reduces length of stay and costs in patients undergoing segmental colonic resections: results from multicenter national administrative database. Am J Surg. 2014 Dec;208(6):919-25; discussion 925. doi: 10.1016/j.amjsurg.2014.08.011. Epub 2014 Sep 22.

    PubMed 25440479

  • Thompson M, Magnuson B. Management of postoperative ileus. Orthopedics. 2012 Mar;35(3):213-7. doi: 10.3928/01477447-20120222-08.

    PubMed 22385598

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alvimopan in people with Post Operative Ileus, run by University of Puerto Rico at 1 site in Puerto Rico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was terminated due to failure to enroll, a low volume of patients met criteria.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03068975, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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