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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 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00663117
The ClinicalTrials.gov registry entry for NCT00663117 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 Placebo is the first listed.
NCT00663117 reports 0 study locations.
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.
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