Document Detail

Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study.
MedLine Citation:
PMID:  23188075     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: There is an unmet need for safe and effective medicines to treat children with Crohn's disease. Recently, investigations have shown an association between endogenous opioid peptides and inflammatory cells.
AIMS: The aims of this study were to evaluate the safety and tolerability of an opioid antagonist, naltrexone, in children with moderate to severe Crohn's disease.
METHODS: A pilot clinical trial was conducted in children with moderate to severe Crohn's disease. Fourteen subjects with a mean age of 12.3 years (range, 8 to 17 y) were enrolled. Children were randomized to placebo or naltrexone (0.1 mg/kg) orally for 8 weeks followed by open-labeled treatment with 8 additional weeks of naltrexone. Safety and toxicity were monitored by physical examinations and blood chemistries. Clinical activity was assessed by the Pediatric Crohn's Disease Activity Index (PCDAI) and Quality of life was monitored by the Impact III survey.
RESULTS: Oral naltrexone was well tolerated without any serious adverse events in children with moderate to severe Crohn's disease. PCDAI scores significantly decreased from pretreatment values (34.2±3.3) with an 8-week course of naltrexone therapy (21.7±3.9) (P=0.005). Twenty-five percent of those treated with naltrexone were considered in remission (score ≤10) and 67% had improved with mild disease activity (decrease in PCDAI score by at least 10 points) at the end of the study. Systemic and social quality of life improved with naltrexone treatment (P=0.035).
CONCLUSIONS: Naltrexone therapy seems safe with limited toxicity when given to children with Crohn's disease and may reduce disease activity.
Jill P Smith; Douglas Field; Sandra I Bingaman; Robert Evans; David T Mauger
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical gastroenterology     Volume:  47     ISSN:  1539-2031     ISO Abbreviation:  J. Clin. Gastroenterol.     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-12     Completed Date:  2013-08-26     Revised Date:  2014-09-18    
Medline Journal Info:
Nlm Unique ID:  7910017     Medline TA:  J Clin Gastroenterol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  339-45     Citation Subset:  IM    
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MeSH Terms
Administration, Oral
Age Factors
Crohn Disease / diagnosis,  drug therapy*
Naltrexone / administration & dosage*,  adverse effects
Narcotic Antagonists / administration & dosage*,  adverse effects
Pilot Projects
Quality of Life
Remission Induction
Severity of Illness Index
Time Factors
Treatment Outcome
Grant Support
Reg. No./Substance:
0/Narcotic Antagonists; 5S6W795CQM/Naltrexone
Comment In:
J Clin Gastroenterol. 2013 Apr;47(4):293-5   [PMID:  23426445 ]
J Clin Gastroenterol. 2014 Sep;48(8):742   [PMID:  24583747 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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