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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by St. John Health System, Michigan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. John Health System, Michigan
ClinicalTrials.gov Identifier:
NCT01050595
First received: January 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 13, 2010
January 13, 2010
December 2009
October 2010   (final data collection date for primary outcome measure)
A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit
Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid-induced Constipation
  • 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.
    Other Name: Relistor
  • Drug: 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.
    Other Name: Relistor
  • Active Comparator: Methylnaltrexone Bromide
    Intervention: Drug: Methylnaltrexone Bromide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo-Normal Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Bradford A Whitmer, D.O. 2482891272 whitmer5@msu.edu
United States
 
NCT01050595
107199
Yes
Bradford Whitmer, DO, Providence Medical Center and Hospital
St. John Health System, Michigan
Not Provided
Principal Investigator: Bradford A Whitmer, D.O. Providence Hospital and Medical Center
St. John Health System, Michigan
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP