Trial of Alvimopan in Major Spine Surgery

NCT02789111 | Completed Phase 4 Results

• 1 other identifier: 18781
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigator has chosen to study the reconstructive spinal surgery patient population because it is believed that the use of alvimopan in these patients at the University of Virginia will give the scientific community significant insight into the broader applicability of this drug into other surgical populations, the impact of this drug on the perception of pain (as opposed to simply the consumption of opioids), and its impact on total hospital charges, resource utilization, and functional outcomes.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Time to First Bowel Movement

  time to first bowel movement after surgery

  Time to event( up to 7 days); From date of day of surgery until the date of first documented bowel movement

Secondary Outcomes (1)

• Time to Resumption of PO Intake

  time to event ( up to 7 days); From date of day of surgery until the date of first documented PO intake

Study Arms (2)

Alvimopan

ACTIVE COMPARATOR

12 mg alvimopan twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.

Drug: Alvimopan

Placebo

PLACEBO COMPARATOR

Placebo twice a day (either by mouth or by (NG) nasogastric tube) for up to seven days post-operatively, or until the time of discharge, whichever occurs first, to a maximum of 15 doses.

Drug: Placebo

Interventions

Alvimopan DRUG

Alviimopan 12 mg twice daily up to 15 doses

Also known as: Entereg

Alvimopan

Placebo DRUG

Placebo twice daily up to 15 doses

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major spine surgery scheduled as part of clinical care
• years

You may not qualify if:

• More than three doses of any opioid within one week of surgery
• Pregnancy
• Prisoners
• Unable to provide consent
• Emergency surgery
• Chronic kidney disease stage 5 (GFR \< 15 ml/min)
• Severe hepatic impairment
• Recent myocardial infarction (within the last 3 months)

Sponsors & Collaborators

• University of Virginia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (13)

• Stambough JL, Beringer D. Postoperative wound infections complicating adult spine surgery. J Spinal Disord. 1992 Sep;5(3):277-85. doi: 10.1097/00002517-199209000-00005.

  PMID: 1520986 BACKGROUND

• Crawford MW, Hickey C, Zaarour C, Howard A, Naser B. Development of acute opioid tolerance during infusion of remifentanil for pediatric scoliosis surgery. Anesth Analg. 2006 Jun;102(6):1662-7. doi: 10.1213/01.ane.0000216036.95705.c2.

  PMID: 16717305 BACKGROUND

• Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019.

  PMID: 10910490 BACKGROUND

• Rauf K, Vohra A, Fernandez-Jimenez P, O'Keeffe N, Forrest M. Remifentanil infusion in association with fentanyl-propofol anaesthesia in patients undergoing cardiac surgery: effects on morphine requirement and postoperative analgesia. Br J Anaesth. 2005 Nov;95(5):611-5. doi: 10.1093/bja/aei237. Epub 2005 Sep 9.

  PMID: 16155034 BACKGROUND

• Cortinez LI, Brandes V, Munoz HR, Guerrero ME, Mur M. No clinical evidence of acute opioid tolerance after remifentanil-based anaesthesia. Br J Anaesth. 2001 Dec;87(6):866-9. doi: 10.1093/bja/87.6.866.

  PMID: 11878688 BACKGROUND

• Fletcher D, Pinaud M, Scherpereel P, Clyti N, Chauvin M. The efficacy of intravenous 0.15 versus 0.25 mg/kg intraoperative morphine for immediate postoperative analgesia after remifentanil-based anesthesia for major surgery. Anesth Analg. 2000 Mar;90(3):666-71. doi: 10.1097/00000539-200003000-00029.

  PMID: 10702454 BACKGROUND

• Lee LH, Irwin MG, Lui SK. Intraoperative remifentanil infusion does not increase postoperative opioid consumption compared with 70% nitrous oxide. Anesthesiology. 2005 Feb;102(2):398-402. doi: 10.1097/00000542-200502000-00024.

  PMID: 15681957 BACKGROUND

• Bell TJ, Poston SA, Kraft MD, Senagore AJ, Delaney CP, Techner L. Economic analysis of alvimopan in North American Phase III efficacy trials. Am J Health Syst Pharm. 2009 Aug 1;66(15):1362-8. doi: 10.2146/ajhp080329.

  PMID: 19635772 BACKGROUND

• 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.

  PMID: 15906123 BACKGROUND

• 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.

  PMID: 19015469 BACKGROUND

• Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. doi: 10.1007/s00464-005-0104-y. Epub 2005 Dec 7.

  PMID: 16333556 BACKGROUND

• 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: 15383800 BACKGROUND

• 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.

  PMID: 16626607 BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bhiken Naik MD
• Organization: University of Virginia Department of Aneshtesiology

BIN4N@hscmail.mcc.virginia.edu

434-924-2283

Study Officials

• Bhiken Naik, MBBCh

  Anesthesiology Attending

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology attending

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 2, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)