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

Opioid-induced Constipation Clinical Trial

— MOVE-IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01050595
• Other study ID #: 107199
• Status: Recruiting
• Phase: Phase 3
• First received: January 13, 2010
• Last updated: January 13, 2010
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2010
• Source: St. John Health System, Michigan
• Contact: Bradford A Whitmer, D.O.
• Phone: 2482891272
• Email: whitmer5[@]msu.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• Methylnaltrexone Bromide
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.
• Placebo-Normal Saline
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.

Locations

Country	Name	City	State
United States	Providence Hospital and Medical Center	Southfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
St. John Health System, Michigan

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes.		Nine months	No
Secondary	Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo.		Nine months	No