DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Beth Israel Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colonic Inertia

Intervention: Methylnaltrexone Bromide (MNTX) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Beth Israel Medical Center

Official(s) and/or principal investigator(s):
Lemeneh Tefera, MD, Principal Investigator, Affiliation: Beth Israel Medical Center
Michael Heller, MD, Study Director, Affiliation: Beth Israel Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Laxation

Secondary outcome: Opioid withdrawal symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2009
Last updated: April 10, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017