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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00949377
Recruitment Status : Withdrawn (Unable to recruit enough patients at a single center.)
First Posted : July 30, 2009
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colonic Inertia Drug: Methylnaltrexone Bromide (MNTX) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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 Name: Relistor

Placebo Comparator: Normal Saline Drug: Placebo
Normal saline




Primary Outcome Measures :
  1. Laxation [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Opioid withdrawal symptoms [ Time Frame: 36 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949377


Sponsors and Collaborators
Beth Israel Medical Center
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Principal Investigator: Lemeneh Tefera, MD Beth Israel Medical Center
Study Director: Michael Heller, MD Beth Israel Medical Center
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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00949377    
Other Study ID Numbers: 064-09
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: April 2015
Keywords provided by Beth Israel Medical Center:
Constipation
opioid
Additional relevant MeSH terms:
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Emergencies
Constipation
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Bromides
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents