Recruiting
Phase 3

Methylnaltrexone

Sponsor:

St. John Health System, Michigan

Code:

NCT01050595

Conditions

Opioid-induced Constipation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylnaltrexone Bromide

Placebo-Normal Saline

Study Details

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.

Conditions

Opioid-induced Constipation

Study ID

NCT01050595

Start date

Dec, 2009

Status verified date

Jan, 2010

Completion date

Dec, 2010

Anticipated

Primary completion date

Oct, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Methylnaltrexone Bromide

placebo comparator: Placebo

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Bradford A Whitmer, D.O.

2482891272whitmer5@msu.edu

Locations

Providence Hospital and Medical Center

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Lynne C Paul, Rn, MSN

248-849-5805lynne.paul@stjohn.org

Nicole D Bolda

248-849-889nicole.bolda@stjohn.org

Principal Investigator:

Bradford A Whitmer, DO

More Information

Sponsor

St. John Health System, Michigan

Last update posted

Jan 15, 2010

Last verified

Jan, 2010

Keywords

  • Intensive Care Unit
  • Constipation
  • Bowel Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. John Health System, Michigan on 2010-01-15.