Status:
COMPLETED
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Crohn's Disease
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief 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 child...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00715117
Start Date
July 1 2008
End Date
August 1 2010
Last Update
September 6 2018
Active Locations (1)
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1
Penn State University hershey Medical center
Hershey, Pennsylvania, United States, 17033