NCT00715117

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing endogenous enkephalin levels in subjects with active Crohn's disease. This is especially important in children who often are suffering from nutritional deprivation which retards their growth. The key objectives are to: 1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers, weight, and pediatric quality of life survey. 2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with active Crohn's Disease. 3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.

Detailed description

The present proposal is designed as double-blinded placebo controlled study involving 30 children between 6-17 years of age with active Crohn's disease. Children will be treated with either naltrexone or placebo for the first 8 weeks then all subjects will receive active naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks after completion of the active drug for safety and to assess Crohn's activity. Low dose naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10 years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg. Half of the subjects in the first 8 weeks will be randomized to placebo which will be either capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form. Children are eligible who are not of child-bearing potential or are using two means of effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or radiographic tests.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Naltrexone	Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks
OTHER	Placebo, sugar pill	Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2010-08-01
• First posted: 2008-07-15
• Last updated: 2018-09-06
• Results posted: 2013-05-30

Locations

1 site across 1 country: United States