IleusNCT02218190
Alvimopan and Ileus in PSF
A study testing Alvimopan in people with Ileus and Spinal Fusion, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus, Spinal Fusion
- 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
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Barnes Jewish Hospital / Washington University in St. Louis School of Medicine
St Louis, Missouri, 63108
About this study
Official title: A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
Read the detailed description
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.
- Conditions
- Ileus, Spinal Fusion
- Being tested
- Alvimopan, Placebo
- Keywords
- Alvimopan, Ileus, Posterior spinal fusion
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlvimopanDrug
Also called Entereg
PlaceboDrug
Also called Sugar Pill
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days or until hospital discharge whichever occurs first
Secondary outcomes (1)
Complications and Adverse Event
Number of patients with complication/adverse event.
Measured: 14 days or until hospital discharge, which ever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Barnes-Jewish Hospital
- Responsible party
- Principal investigator, Michael Kelly, Washington University School of Medicine
- Investigators
- Michael P Kelly, MD, Principal investigator, Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218190
- Sponsor's protocol ID
- 201401126
- Status last verified
- May 2019
- First submitted
- 13 Aug 2014
- Last updated
- 17 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 11755891Senagore 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.
PubMed 17909274Leslie 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.
PubMed 16076918Holzer 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.
PubMed 15135926Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-71. doi: 10.2165/00003495-200363070-00003.
PubMed 12656645Sternini 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.
PubMed 15357847Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
PubMed 15017498Holte 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 11091234Zimmerman 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.
PubMed 8057274Delaney 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 15906123Liu 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.
PubMed 11180040Viscusi 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.
PubMed 16333556Wolff 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.
PubMed 15383800Buchler 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.
PubMed 19086236Wolff 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.
PubMed 17617331
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT02218190
- Acronym / sponsor ID
- 201401126
- Conditions
- Ileus, Spinal Fusion
- Keywords
- Alvimopan, Ileus, Posterior spinal fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Orthopedic Research and Education Foundation, Barnes-Jewish Hospital
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alvimopan | Experimental | Drug: AlvimopanAlvimopan 12mg once orally two hours prior to surgery and then 2 mg orally twice a day until post-operative day (POD) seven. |
| Placebo - Sugar Pill | Placebo comparator | Drug: PlaceboPlacebo Sugar Pill orally two hours prior to surgery and then one sugar pill orally twice a day until post-operative day (POD) seven |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing elective PSF of at least 5 levels and/or fixation to pelvis
Key exclusion criteria (8 listed)
- pregnant women
- ischemic heart disease
- chronic liver or renal disease
- prior bowel resection
- presence of colostomy or ileostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlvimopanAlso: Entereg | Drug | Alvimopan |
| PlaceboAlso: Sugar Pill | Drug | Placebo - Sugar Pill |
Primary outcome
Recovery of Bowel Function
Time frame: 14 days or until hospital discharge whichever occurs first
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.
Length of Hospital Stay
Time frame: 14 days or until hospital discharge whichever occurs first
To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.
1 secondary outcome
Complications and Adverse Event
Time frame: 14 days or until hospital discharge, which ever occurs first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11755891Kehlet 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.
- Background: PubMed 17909274Senagore 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.
- Background: PubMed 16076918Leslie 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.
- Background: PubMed 15135926Holzer 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.
- Background: PubMed 12656645Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-71. doi: 10.2165/00003495-200363070-00003.
- Background: PubMed 15357847Sternini 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.
- Background: PubMed 15017498Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
- Background: PubMed 11091234Holte 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.
- Background: PubMed 8057274Zimmerman 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.
- Background: PubMed 15906123Delaney 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.
- Background: PubMed 11180040Liu 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.
- Background: PubMed 16333556Viscusi 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.
- Summary Review for Regulatory ActionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Kelly, MD principal investigator
Department of Orthopedic Surgery - Washington University in St. Louis School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alvimopan in people with Ileus and Spinal Fusion, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 17 May 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 14 days or until hospital discharge whichever occurs first). The study lists 2 primary outcomes in all. 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 NCT02218190, which also lists 15 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 17 May 2019.