Abstract | BACKGROUND: OBJECTIVE: DESIGN: Double-blind, randomized, parallel-group, placebo-controlled, hypothesis-generating phase 2 study. SETTING: Sixteen US hospitals and rehabilitation facilities. PATIENTS: INTERVENTIONS: Patients received once-daily subcutaneous methylnaltrexone 12 mg or placebo for up to 4 or 7 days. MEASUREMENTS: All endpoints were exploratory and included the percentage of patients achieving laxation within 2 and 4 hours of first dose and time to laxation. RESULTS: Thirty-three patients received at least 1 dose of study drug ( methylnaltrexone, n = 18; placebo, n = 15). Within 2 and 4 hours, significantly more patients receiving methylnaltrexone achieved laxation (2 hours: 33.3% vs 0%, P = 0.021; 4 hours: 38.9% vs 6.7%, P = 0.046) compared with placebo. Time to laxation was significantly shorter with methylnaltrexone (median = 15.8 hours) versus placebo (median = 50.9 hours), P = 0.0197. The most common adverse events related to the gastrointestinal tract. Pain scores remained stable and were similar to those of placebo, and signs and symptoms of opioid withdrawal did not emerge in patients receiving methylnaltrexone. CONCLUSIONS:
|
Authors | Lucas Anissian, Harry W Schwartz, Kevin Vincent, Heather K Vincent, Jennifer Carpenito, Nancy Stambler, Tage Ramakrishna |
Journal | Journal of hospital medicine
(J Hosp Med)
Vol. 7
Issue 2
Pg. 67-72
(Feb 2012)
ISSN: 1553-5606 [Electronic] United States |
PMID | 21998076
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Copyright | Copyright © 2011 Society of Hospital Medicine. |
Chemical References |
- Analgesics, Opioid
- Narcotic Antagonists
- Quaternary Ammonium Compounds
- methylnaltrexone
- Naltrexone
|
Topics |
- Aged
- Analgesics, Opioid
(adverse effects)
- Constipation
(chemically induced, drug therapy)
- Double-Blind Method
- Female
- Humans
- Injections, Subcutaneous
- Male
- Middle Aged
- Naltrexone
(administration & dosage, analogs & derivatives)
- Narcotic Antagonists
(administration & dosage)
- Orthopedic Procedures
- Pilot Projects
- Quaternary Ammonium Compounds
(administration & dosage)
- Rehabilitation
(methods)
- Treatment Outcome
|