Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
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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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colonic Inertia | Drug: Methylnaltrexone Bromide (MNTX) Drug: Placebo | Phase 4 |
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 |

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 |
- Laxation [ Time Frame: 4 hours ]
- Opioid withdrawal symptoms [ Time Frame: 36 hours ]

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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 |
Inclusion Criteria
- Age 18 and greater
- Clinical diagnosis of constipation
- 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)
- Patients must have previously tried a stable laxative regiment for at least three (3) days prior to study entry.
- 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.
- 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.
- Willing to comply with study instructions and sign an informed consent
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

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
Principal Investigator: | Lemeneh Tefera, MD | Beth Israel Medical Center | |
Study Director: | Michael Heller, MD | Beth Israel Medical Center |
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 |
Constipation opioid |
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 |