NCT02218190

Brief Summary

The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

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

August 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 17, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

August 13, 2014

Results QC Date

April 1, 2019

Last Update Submit

May 15, 2019

Conditions

IleusSpinal Fusion

Keywords

AlvimopanIleusPosterior spinal fusion

Outcome Measures

Primary Outcomes (2)

  • Recovery of Bowel Function

    To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement.

    14 days or until hospital discharge whichever occurs first

  • Length of Hospital Stay

    To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.

    14 days or until hospital discharge whichever occurs first

Secondary Outcomes (1)

  • Complications and Adverse Event

    14 days or until hospital discharge, which ever occurs first

Study Arms (2)

Alvimopan

EXPERIMENTAL

Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.

Drug: Alvimopan

Placebo - Sugar Pill

PLACEBO COMPARATOR

Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven

Drug: Placebo

Interventions

AlvimopanDRUG
Also known as: Entereg
Alvimopan
PlaceboDRUG
Also known as: Sugar Pill
Placebo - Sugar Pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis

You may not qualify if:

  • pregnant women
  • ischemic heart disease
  • chronic liver or renal disease
  • prior bowel resection
  • presence of colostomy or ileostomy
  • gastroparesis
  • complete bowel obstruction
  • inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital / Washington University in St. Louis School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (15)

  • Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. doi: 10.1016/s0002-9610(01)00781-4.

    PMID: 11755891BACKGROUND

  • Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7. doi: 10.2146/ajhp070428.

    PMID: 17909274BACKGROUND

  • Leslie JB. Alvimopan for the management of postoperative ileus. Ann Pharmacother. 2005 Sep;39(9):1502-10. doi: 10.1345/aph.1E615. Epub 2005 Aug 2.

    PMID: 16076918BACKGROUND

  • Holzer P. Opioids and opioid receptors in the enteric nervous system: from a problem in opioid analgesia to a possible new prokinetic therapy in humans. Neurosci Lett. 2004 May 6;361(1-3):192-5. doi: 10.1016/j.neulet.2003.12.004.

    PMID: 15135926BACKGROUND

  • Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-71. doi: 10.2165/00003495-200363070-00003.

    PMID: 12656645BACKGROUND

  • Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16. doi: 10.1111/j.1743-3150.2004.00553.x.

    PMID: 15357847BACKGROUND

  • Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.

    PMID: 15017498BACKGROUND

  • 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.

    PMID: 11091234BACKGROUND

  • Zimmerman DM, Gidda JS, Cantrell BE, Schoepp DD, Johnson BG, Leander JD. Discovery of a potent, peripherally selective trans-3,4-dimethyl-4-(3-hydroxyphenyl)piperidine opioid antagonist for the treatment of gastrointestinal motility disorders. J Med Chem. 1994 Jul 22;37(15):2262-5. doi: 10.1021/jm00041a003.

    PMID: 8057274BACKGROUND

  • 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: 15906123BACKGROUND

  • Liu SS, Hodgson PS, Carpenter RL, Fricke JR Jr. ADL 8-2698, a trans-3,4-dimethyl-4-(3-hydroxyphenyl) piperidine, prevents gastrointestinal effects of intravenous morphine without affecting analgesia. Clin Pharmacol Ther. 2001 Jan;69(1):66-71. doi: 10.1067/mcp.2001.112680.

    PMID: 11180040BACKGROUND

  • 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: 16333556BACKGROUND

  • 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: 15383800BACKGROUND

  • Buchler MW, Seiler CM, Monson JR, Flamant Y, Thompson-Fawcett MW, Byrne MM, Mortensen ER, Altman JF, Williamson R. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. Aliment Pharmacol Ther. 2008 Aug 1;28(3):312-25. doi: 10.1111/j.1365-2036.2008.03696.x.

    PMID: 19086236BACKGROUND

  • Wolff BG, Viscusi ER, Delaney CP, Du W, Techner L. Patterns of gastrointestinal recovery after bowel resection and total abdominal hysterectomy: pooled results from the placebo arms of alvimopan phase III North American clinical trials. J Am Coll Surg. 2007 Jul;205(1):43-51. doi: 10.1016/j.jamcollsurg.2007.02.026. Epub 2007 May 17.

    PMID: 17617331BACKGROUND

Related Links

MeSH Terms

Conditions

Ileus

Interventions

alvimopanSugars

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Michael P. Kelly, MD, MSc
Organization
Washington University School of Medicine
kellymi@wustl.edu
314-747-2511

Study Officials

  • Michael P Kelly, MD

    Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
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
Assistant Prof. Department of Orthopedic Surgery

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2019

Last Updated

May 17, 2019

Results First Posted

May 17, 2019

Record last verified: 2019-05

Locations

US(1)