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This study has been withdrawn prior to enrollment.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:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00949377
First received: July 29, 2009
Last updated: January 14, 2011
Last verified: January 2011
  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
Constipation
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 ]

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (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 and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

Responsible Party: Can methylnaltrexone safely treat opioid related constipation in the emergency department? A randomized double blind placebo controlled study., 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: January 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Medical Center:
Constipation
opioid

Additional relevant MeSH terms:
Constipation
Emergencies
Signs and Symptoms, Digestive
Signs and Symptoms
Disease Attributes
Pathologic Processes
Bromides
Methylnaltrexone
Naltrexone
Analgesics, Opioid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 29, 2014