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Clinical Trials/NCT00949377
NCT00949377WithdrawnPhase 4

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

Beth Israel Medical Center0 sitesStarted: September 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Primary Endpoint
Laxation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Arms & Interventions

Methylnaltrexone Bromide

Experimental

Intervention: Methylnaltrexone Bromide (MNTX) (Drug)

Normal Saline

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Laxation

Time Frame: 4 hours

Secondary Outcomes

  • Opioid withdrawal symptoms(36 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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