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

• ClinicalTrials.gov Identifier: NCT00949377
• Recruitment Status: Withdrawn
• First Posted: July 30, 2009
• Last Update Posted: October 14, 2015
• Sponsor: Beth Israel Medical Center
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Beth Israel Medical Center

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Laxation [ Time Frame: 4 hours ]

Secondary Outcome Measures :

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

Eligibility Criteria

• 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

Contacts and Locations

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
• Other Study ID Numbers: 064-09
• First Posted: July 30, 2009
• Last Update Posted: October 14, 2015
• Last Verified: April 2015

Keywords provided by Beth Israel Medical Center:

Constipation; opioid

Additional relevant MeSH terms:

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