NCT01050595

Brief Summary

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

10 months

First QC Date

January 13, 2010

Last Update Submit

January 13, 2010

Conditions

Opioid-induced Constipation

Keywords

Intensive Care UnitConstipationBowel Management

Outcome Measures

Primary Outcomes (1)

  • A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.

    Nine months

Secondary Outcomes (1)

  • Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.

    Nine months

Study Arms (2)

Methylnaltrexone Bromide

ACTIVE COMPARATOR
Drug: Methylnaltrexone Bromide

Placebo

PLACEBO COMPARATOR
Drug: Placebo-Normal Saline

Interventions

Methylnaltrexone BromideDRUG

The experimental group will receive the recommended dose of MNTX (Relistor) is 8 mg for patients weighing 38 kg to less than 62 kg (84 lbs to less than 136 lbs) or 12 mg for patients weighing 62 kg to 114 kg (136 lbs to 251 lbs). Patients whose weight is below 38 kg or greater than 114 kg, will be dosed at 0.15 mg/kg. If creatinine clearance \<30 will decrease dose by 50%. This will be given after 72 hours of no bowel movement. Bowel management protocol will be instituted four hours afterward with the methylnaltrexone being given every other day.

Also known as: Relistor
Methylnaltrexone Bromide
Placebo-Normal SalineDRUG

Control group will be given an equal amount of normal saline in an identically appearing vial every other day until a bowel movement occurs. A bowel management protocol will also be started.

Also known as: Relistor
Placebo

Eligibility Criteria

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

You may qualify if:

  • years of age or older in the ICU
  • Opioids for analgesia for at least 24 hours.
  • Opioid-induced constipation with no bowel movement within the last 72 hours.
  • Women of childbearing potential had negative pregnancy tests.

You may not qualify if:

  • Contraindication to use of the GI tract
  • Diarrhea on admission
  • Bowel surgery within 8 weeks of admission
  • Ileostomy or colostomy
  • Not expected to live or stay more than 3 days in the intensive care unit
  • Constipation that was not primarily caused by opioids (as determined by the investigator)
  • No opioid use in the last 24 hours,
  • Mechanical gastrointestinal obstruction
  • An indwelling peritoneal catheter
  • Clinically active diverticular disease
  • Fecal impaction
  • Acute surgical abdomen
  • History of Crohn's disease or ulcerative colitis
  • On Palliative care
  • Less than 18 years old
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence Hospital and Medical Center

Southfield, Michigan, 48075, United States

RECRUITING

Related Publications (11)

  • Ritchie G, Burgess L, Mostafa S, Wenstone R. Preventing constipation in critically ill patients. Nurs Times. 2008 Nov 18-24;104(46):42-4.

    PMID: 19054971BACKGROUND

  • Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.

    PMID: 16803421BACKGROUND

  • Chappell D, Rehm M, Conzen P. Opioid-induced constipation in intensive care patients: relief in sight? Crit Care. 2008;12(4):161. doi: 10.1186/cc6930. Epub 2008 Jul 1.

    PMID: 18598388BACKGROUND

  • Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.

    PMID: 14633751BACKGROUND

  • Tittle M, McMillan SC. Pain and pain-related side effects in an ICU and on a surgical unit: nurses' management. Am J Crit Care. 1994 Jan;3(1):25-30.

    PMID: 7906992BACKGROUND

  • Viscusi ER, Gan TJ, Leslie JB, Foss JF, Talon MD, Du W, Owens G. Peripherally acting mu-opioid receptor antagonists and postoperative ileus: mechanisms of action and clinical applicability. Anesth Analg. 2009 Jun;108(6):1811-22. doi: 10.1213/ane.0b013e31819e0d3a.

    PMID: 19448206BACKGROUND

  • Arpino PA, Thompson BT. Safety of enteral naloxone for the reversal of opiate-induced constipation in the intensive care unit. J Clin Pharm Ther. 2009 Apr;34(2):171-5. doi: 10.1111/j.1365-2710.2008.00982.x.

    PMID: 19250137BACKGROUND

  • McKenna S, Wallis M, Brannelly A, Cawood J. The nursing management of diarrhoea and constipation before and after the implementation of a bowel management protocol. Aust Crit Care. 2001 Feb;14(1):10-6. doi: 10.1016/s1036-7314(01)80017-5.

    PMID: 11899755BACKGROUND

  • Dorman BP, Hill C, McGrath M, Mansour A, Dobson D, Pearse T, Singleton J, Al-Omoush A, Barry M, Colongon AR, Perez M, Fitzgerald D, Zabala M. Bowel management in the intensive care unit. Intensive Crit Care Nurs. 2004 Dec;20(6):320-9. doi: 10.1016/j.iccn.2004.09.004.

    PMID: 15567673BACKGROUND

  • Hill S, Anderson J, Baker K, Bonson B, Gager M, Lake E. Management of constipation in the critically ill patient. Nurs Crit Care. 1998 May-Jun;3(3):134-7.

    PMID: 9883173BACKGROUND

  • Sanz Rubiales A, del Valle Rivero ML. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 Sep 4;359(10):1070-1; author reply 1071. doi: 10.1056/NEJMc081373. No abstract available.

    PMID: 18768955BACKGROUND

MeSH Terms

Conditions

Opioid-Induced ConstipationConstipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Bradford A Whitmer, D.O.

    Providence Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradford A Whitmer, D.O.

CONTACT

2482891272whitmer5@msu.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

December 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(1)