Expired Study
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Saint Louis, Missouri 63108


Purpose:

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


Study summary:

Posterior spinal fusion (PSF) is a common orthopaedic procedure associated with a high incidence of post-operative ileus (POI) and concomitant increased length of hospital stay (LOHS). POI is exacerbated by high dose opiate consumption often required by these patients post-operatively. We propose a randomized, double-blinded, placebo-controlled pilot trial studying the use of alvimopan, a peripherally-acting mu-opioid receptor antagonist known to reduce POI in bowel resection. We hypothesize that alvimopan will shorten POI in spine fusion patients without negatively affecting post-operative pain control. Treatment efficacy will be assessed by recording time to first bowel movement, time to hospital discharge, and post-operative pain control. We hypothesize that acute administration of alvimopan, a peripherally-acting mu-opioid antagonist, shortens the duration of post-operative ileus (POI) in patients undergoing long-segment (5 or greater thoracolumbar levels) posterior spinal fusion (PSF). The study will be a randomized, double-blinded, placebo-controlled pilot trial. Reducing the morbidity of POI in patients undergoing PSF will decrease hospital stay and costs, and also improve patient satisfaction and post-operative care after major orthopaedic surgery.


Criteria:

Inclusion Criteria: - adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis Exclusion Criteria: - 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).


Study is Available At:


Original ID:

201401126


NCT ID:

NCT02218190


Secondary ID:


Study Acronym:


Brief Title:

Alvimopan and Ileus in PSF


Official Title:

A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

31


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael P Kelly, MD
Principal Investigator
Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine

Study Dates

Start Date:August 2014
Completion Date:January 2019
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 15, 2019
First Received Date:August 13, 2014
First Results Date:April 1, 2019

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Complications and Adverse Event
Time Frame:14 days or until hospital discharge, which ever occurs first
Safety Issues:False
Description:Number of patients with complication/adverse event.
Outcome Type:Primary Outcome
Measure:Length of Hospital Stay
Time Frame:14 days or until hospital discharge whichever occurs first
Safety Issues:False
Description:To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.
Outcome Type:Primary Outcome
Measure:Recovery of Bowel Function
Time Frame:14 days or until hospital discharge whichever occurs first
Safety Issues:False
Description: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. Ti

Study Interventions

Intervention Type:Drug
Name:Alvimopan
Arm Name:Alvimopan
Other Name:Entereg
Intervention Type:Drug
Name:Placebo
Arm Name:Placebo - Sugar Pill
Other Name:Sugar Pill

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo - Sugar Pill
Description:Placebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven
Study Arm Type:Experimental
Arm Name:Alvimopan
Description:Alvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:Orthopedic Research and Education Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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. Epub 2007 May 17.
PMID:17617331
Reference Type:Reference
Citation:Büchler 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.
PMID:19086236
Reference Type:Reference
Citation: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.
PMID:15383800
Reference Type:Reference
Citation: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. Epub 2005 Dec 7. Erratum in: Surg Endosc. 2006 Mar;20(3):537.
PMID:16333556
Reference Type:Reference
Citation: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.
PMID:11180040
Reference Type:Reference
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.
PMID:15906123
Reference Type:Reference
Citation: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.
PMID:8057274
Reference Type:Reference
Citation:Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. Review.
PMID:11091234
Reference Type:Reference
Citation:Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. Review.
PMID:15017498
Reference Type:Reference
Citation:Sternini C, Patierno S, Selmer IS, Kirchgessner A. The opioid system in the gastrointestinal tract. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:3-16.
PMID:15357847
Reference Type:Reference
Citation:Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-71. Review.
PMID:12656645
Reference Type:Reference
Citation: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. Review.
PMID:15135926
Reference Type:Reference
Citation:Leslie JB. Alvimopan for the management of postoperative ileus. Ann Pharmacother. 2005 Sep;39(9):1502-10. Epub 2005 Aug 2. Review.
PMID:16076918
Reference Type:Reference
Citation: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. Review.
PMID:17909274
Reference Type:Reference
Citation:Kehlet H, Holte K. Review of postoperative ileus. Am J Surg. 2001 Nov;182(5A Suppl):3S-10S. Review.
PMID:11755891

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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