NCT00949377

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-07-30
• Last updated: 2015-10-14