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

Sponsor
Beth Israel Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00949377
Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
0
Enrollment
2
Arms
27
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Methylnaltrexone Bromide (MNTX)
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylnaltrexone Bromide

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.
Other Names:
  • Relistor

    		•
    Placebo Comparator: Normal Saline

    Drug: Placebo
    Normal saline

    Outcome Measures

    Primary Outcome Measures

    1. Laxation [4 hours]

    Secondary Outcome Measures

    1. Opioid withdrawal symptoms [36 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beth Israel Medical Center
    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Principal Investigator: Lemeneh Tefera, MD, Beth Israel Medical Center
    • Study Director: Michael Heller, MD, Beth Israel Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beth Israel Medical Center
    ClinicalTrials.gov Identifier:
    NCT00949377
    Other Study ID Numbers:
    • 064-09
    First Posted:
    Jul 30, 2009
    Last Update Posted:
    Oct 14, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Beth Israel Medical Center
    Constipation
    opioid
    Additional relevant MeSH terms:
    Emergencies
    Constipation
    Bromides
    Methylnaltrexone

    Study Results

    No Results Posted as of Oct 14, 2015