Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
NCT00949377
ABOUT THIS STUDY
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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
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
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Descriptive Information | |||||||
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Brief Title ICMJE | Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department? | ||||||
Official Title ICMJE | Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department? | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE | Colonic Inertia | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Withdrawn | ||||||
Actual Enrollment ICMJE | 0 | ||||||
Original Estimated Enrollment ICMJE | 60 | ||||||
Actual Study Completion Date ICMJE | December 2011 | ||||||
Actual Primary Completion Date | December 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00949377 | ||||||
Other Study ID Numbers ICMJE | 064-09 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Beth Israel Medical Center | ||||||
Study Sponsor ICMJE | Beth Israel Medical Center | ||||||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Beth Israel Medical Center | ||||||
Verification Date | April 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |