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

Sponsor

St. John Health System, Michigan (Other)

Overall Status

Unknown status

CT.gov ID

NCT01050595

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2009

Anticipated Primary Completion Date :

Oct 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

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 Names: 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 Names: Relistor

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 Names:

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 Names:

Relistor

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.