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NCT00715117 · ClinicalTrials.gov registry record · Phase 2
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
A Phase 2 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT00715117: Completed Phase 2 study, sponsored by Milton S. Hershey Medical Center.
NCT00715117 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00715117, a Phase 2 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
Using adverse events and laboratory values Safety \& toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.
Interventions
- DRUG Naltrexone
- OTHER Placebo, sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT00715117 record still lists
NCT00715117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.
NCT00715117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00715117 about?
NCT00715117 is a clinical study titled "The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease". 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 object...
What is the current status of trial NCT00715117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2008-07. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00715117?
The interventions under investigation include: Naltrexone (DRUG), Placebo, sugar pill (OTHER).
Who is sponsoring clinical trial NCT00715117?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00715117's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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