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Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?

NCT00949377 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-10-14

No results posted yet for this study

Summary

The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.

Conditions

  • Colonic Inertia

Interventions

DRUG

Methylnaltrexone Bromide (MNTX)

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.

DRUG

Placebo

Normal saline

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • Lemeneh Tefera, MD · Beth Israel Medical Center

  • Michael Heller, MD · Beth Israel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-12-31
Completion
2011-12-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00949377 on ClinicalTrials.gov