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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 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00715117
The ClinicalTrials.gov registry entry for NCT00715117 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.
NCT00715117 reports 0 study locations.
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.
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