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NCT00580606 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00580606: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00580606 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00580606, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.
Primary Outcome
Desensitization Assessment: Participants who successfully consumed without dose-limiting symptoms 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline oral food challenge during a double-blind placebo-controlled oral food challenge were counted as successes.
Interventions
- DRUG Glycerinated peanut allergenic extract
- DRUG Placebo for peanut extract (glycerin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT00580606 record still lists
NCT00580606 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Glycerinated peanut allergenic extract is the first listed.
NCT00580606 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00580606 about?
NCT00580606 is a clinical study titled "A Randomized, Double-Blind Placebo-Controlled Peanut Sublingual Immunotherapy Trial". The purpose of this study is to evaluate the safety and immune response to daily sublingual (under the tongue) immunotherapy (SLIT) with peanut extract in adults and children with peanut allergies.
What is the current status of trial NCT00580606?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2007-12. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00580606?
The interventions under investigation include: Glycerinated peanut allergenic extract (DRUG), Placebo for peanut extract (glycerin) (DRUG).
Who is sponsoring clinical trial NCT00580606?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00580606's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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