Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
This study has been withdrawn prior to enrollment.
(Unable to recruit enough patients at a single center.)
Sponsor:
Beth Israel Medical Center
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00949377
First received: July 29, 2009
Last updated: October 13, 2015
Last verified: April 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colonic Inertia |
Drug: Methylnaltrexone Bromide (MNTX) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department? |
Resource links provided by NLM:
Further study details as provided by Beth Israel Medical Center:
Primary Outcome Measures:
- Laxation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Opioid withdrawal symptoms [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949377
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949377
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 |
More Information
| Responsible Party: | Beth Israel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00949377 History of Changes |
| Other Study ID Numbers: | 064-09 |
| Study First Received: | July 29, 2009 |
| Last Updated: | October 13, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Beth Israel Medical Center:
|
Constipation opioid |
Additional relevant MeSH terms:
|
Emergencies Constipation Disease Attributes Pathologic Processes Signs and Symptoms, Digestive Signs and Symptoms Analgesics, Opioid Methylnaltrexone Naltrexone |
Bromides Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists Anticonvulsants |
ClinicalTrials.gov processed this record on September 30, 2016