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

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ClinicalTrials.gov Identifier: NCT01050595
Recruitment Status : Unknown
Verified January 2010 by St. John Health System, Michigan.
Recruitment status was:  Recruiting
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:
St. John Health System, Michigan

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.

Condition or disease Intervention/treatment Phase
Opioid-induced Constipation Drug: Methylnaltrexone Bromide Drug: Placebo-Normal Saline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Methylnaltrexone for the Reversal of Opiate-Induced Constipation in the Intensive Care Unit
Study Start Date : December 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Methylnaltrexone Bromide 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
Placebo Comparator: Placebo 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



Primary Outcome Measures :
  1. A significantly higher incidence of a rescue free laxation with methylnaltrexone within 4 hours +- 45 minutes. [ Time Frame: Nine months ]

Secondary Outcome Measures :
  1. Decreased need for rescue medications to have a bowel movement in the treatment arm vs placebo. [ Time Frame: Nine months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050595


Contacts
Contact: Bradford A Whitmer, D.O. 2482891272 whitmer5@msu.edu

Locations
United States, Michigan
Providence Hospital and Medical Center Recruiting
Southfield, Michigan, United States, 48075
Contact: Lynne C Paul, Rn, MSN    248-849-5805    lynne.paul@stjohn.org   
Contact: Nicole D Bolda    248-849-889    nicole.bolda@stjohn.org   
Principal Investigator: Bradford A Whitmer, DO         
Sponsors and Collaborators
St. John Health System, Michigan
Investigators
Principal Investigator: Bradford A Whitmer, D.O. Providence Hospital and Medical Center

Publications:

Responsible Party: Bradford Whitmer, DO, Providence Medical Center and Hospital
ClinicalTrials.gov Identifier: NCT01050595     History of Changes
Other Study ID Numbers: 107199
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by St. John Health System, Michigan:
Intensive Care Unit
Constipation
Bowel Management

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bromides
Methylnaltrexone
Naltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents