Clinical trial NCT00949377: Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Official title: Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Colonic Inertia
Keywords: Constipation
opioid
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2009-07-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Laxation
timeFrame: 4 hours
Secondary outcomes:
measure: Opioid withdrawal symptoms
timeFrame: 36 hours
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Medical Center
name: Lemeneh Tefera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medical Center
name: Michael Heller, MD
role: STUDY_DIRECTOR
References: