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Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit (MOVE-IT)

Primary Purpose

Opioid-induced Constipation

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Methylnaltrexone Bromide

Placebo-Normal Saline

About this trial

This is an interventional treatment trial for Opioid-induced Constipation focused on measuring Intensive Care Unit, Constipation, Bowel Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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.

Exclusion Criteria:

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
Bowel movement in last 72 hours.

Sites / Locations

Providence Hospital and Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylnaltrexone Bromide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01050595

First Posted

January 13, 2010

Last Updated

January 13, 2010

Sponsor

St. John Health System, Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01050595

Brief Title

Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

Acronym

MOVE-IT

Official Title

Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

St. John Health System, Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-induced Constipation

Keywords

Intensive Care Unit, Constipation, Bowel Management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Methylnaltrexone Bromide

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Methylnaltrexone Bromide

Other Intervention Name(s)

Relistor

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo-Normal Saline

Other Intervention Name(s)

Relistor

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Nine months

Secondary Outcome Measure Information:

Title

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

Time Frame

Nine months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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. Exclusion Criteria: 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 Bowel movement in last 72 hours.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bradford A Whitmer, D.O.

Phone

2482891272

whitmer5@msu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradford A Whitmer, D.O.

Organizational Affiliation

Providence Hospital and Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Hospital and Medical Center

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48075

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lynne C Paul, Rn, MSN

Phone

248-849-5805

lynne.paul@stjohn.org

First Name & Middle Initial & Last Name & Degree

Nicole D Bolda

Phone

248-849-889

nicole.bolda@stjohn.org

First Name & Middle Initial & Last Name & Degree

Bradford A Whitmer, DO

12. IPD Sharing Statement

Citations:

PubMed Identifier

19054971

Citation

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

Results Reference

background

PubMed Identifier

16803421

Citation

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.

Results Reference

background

PubMed Identifier

18598388

Citation

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.

Results Reference

background

PubMed Identifier

14633751

Citation

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.

Results Reference

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PubMed Identifier

7906992

Citation

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.

Results Reference

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PubMed Identifier

19448206

Citation

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.

Results Reference

background

PubMed Identifier

19250137

Citation

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.

Results Reference

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PubMed Identifier

11899755

Citation

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.

Results Reference

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PubMed Identifier

15567673

Citation

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.

Results Reference

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PubMed Identifier

9883173

Citation

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.

Results Reference

background

PubMed Identifier

18768955

Citation

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.

Results Reference

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Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

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