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NCT03482479 · ClinicalTrials.gov registry record · Phase 2
Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03482479: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT03482479 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03482479, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis. The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.
Interventions
- OTHER Placebo Comparator
- DRUG Naltrexone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-02-04 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03482479
The ClinicalTrials.gov registry entry for NCT03482479 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT03482479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03482479 about?
NCT03482479 is a clinical study titled "Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis". Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple s...
What is the current status of trial NCT03482479?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2019-02-04. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT03482479?
The interventions under investigation include: Placebo Comparator (OTHER), Naltrexone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03482479?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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