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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center; Penn State University
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

• All subjects must give written informed consent by parent or guardian

• Male or female subjects, > 6 - 17 years

• Patients must have endoscopic or radiographic confirmed Crohn's Disease.

• Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.

Exclusion Criteria:

• Adolescent women of childbearing potential and / or sexually active unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.

• Adolescent women who are pregnant or breastfeeding

• Subjects with an ostomy or ileocolic anastomosis from surgery as these operations interfere with the PCDAI assessment

• Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be discontinued 4 weeks prior to study initiation.

• Patients with abnormal liver function tests

• Prednisone greater than 10 mg or > 0.2 mg/kg orally