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NCT00663117 · ClinicalTrials.gov registry record · Phase 2
The Effects of Naltrexone on Active Crohn's Disease
A Phase 2 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00663117: Completed Phase 2 study, sponsored by Milton S. Hershey Medical Center.
NCT00663117 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00663117, a Phase 2 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed: 1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys; 2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response; 3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and 4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy. Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.
Primary Outcome
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
Interventions
- DRUG Placebo
- DRUG Naltrexone-HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00663117 record still lists
NCT00663117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00663117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00663117 about?
NCT00663117 is a clinical study titled "The Effects of Naltrexone on Active Crohn's Disease". It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed: 1. Evaluate the effects of low dose naltrexone ...
What is the current status of trial NCT00663117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2006-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00663117?
The interventions under investigation include: Placebo (DRUG), Naltrexone-HCl (DRUG).
Who is sponsoring clinical trial NCT00663117?
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 NCT00663117's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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