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

Phase 4

Withdrawn

• Conditions: Colonic Inertia
• Interventions: Drug: Placebo; Drug: Methylnaltrexone Bromide (MNTX)

• Registration Number: NCT00949377
• Lead Sponsor: Beth Israel Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Study Start: 2009-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnancy or lactation
2. Recent surgery within six (6) weeks of the emergency department visit
3. Opioid withdrawal syndrome as determined by clinical judgment.
4. Patients with previous history of diabetic gastroparesis.
5. Any patient who has known or suspected gastrointestinal obstruction
6. Any patients with creatinine clearance ≤ 30 mL/min
7. Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
8. Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
9. Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
10. A known history of substance abuse on methadone maintenance therapy > 12 months
11. Allergy or contraindication to use of methylnaltrexone
12. Prior enrollment in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	-
Methylnaltrexone Bromide	Methylnaltrexone Bromide (MNTX)	-

Primary Outcome Measures

Name	Time	Method
Laxation	4 hours

Secondary Outcome Measures

Name	Time	Method
Opioid withdrawal symptoms	36 hours