Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Information source: Beth Israel Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colonic Inertia
Intervention: Methylnaltrexone Bromide (MNTX) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Beth Israel Medical Center Official(s) and/or principal investigator(s): Lemeneh Tefera, MD, Principal Investigator, Affiliation: Beth Israel Medical Center Michael Heller, MD, Study Director, Affiliation: Beth Israel Medical Center
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.
Clinical Details
Official title: Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Laxation
Secondary outcome: Opioid withdrawal symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
1. Age 18 and greater
2. Clinical diagnosis of constipation
3. Any patients that report taking an opioid analgesic for greater than two (2) weeks
(eg known oncology patients and chronic pain syndrome patients, including those with
low back pain or sciatica)
4. Patients must have previously tried a stable laxative regiment for at least three (3)
days prior to study entry.
5. All patients will have a flat and upright abdominal x-ray, and chest x-ray to exclude
gastrointestinal (GI) obstruction. Any patients who have radiographic evidence of GI
obstruction will need a CT scan of the abdomen to exclude GI obstruction prior to
study enrollment.
6. Females of childbearing potential must have a negative pregnancy test and must be
encouraged to use appropriate birth control for a period after the study.
7. Willing to comply with study instructions and sign an informed consent
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
Locations and Contacts
Additional Information
Starting date: September 2009
Last updated: April 10, 2015
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