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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00715117
Date of registration: 14/07/2008
Prospective Registration: Yes
Primary sponsor: Milton S. Hershey Medical Center
Public title: The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease LDN-Ped
Scientific title: The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Date of first enrolment: July 2008
Target sample size: 14
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Name:     Jill P Smith, MD
Affiliation:  Pennsylvania State University College of Medicine
Key inclusion & exclusion 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-a 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

Age minimum: 6 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: Naltrexone
Other: Placebo, sugar pill
Primary Outcome(s)
Number of Patients Reporting Side Effects [Time Frame: 8 weeks or 16 weeks]
Secondary Outcome(s)
Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy [Time Frame: 16 weeks]
Pediatric Crohn's Disease Activity Index Score (PCDAI) [Time Frame: Pretreatment and 8 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 30/05/2013
Date Completed:
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