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NCT00597675 · ClinicalTrials.gov registry record · Phase 2
Oral Immunotherapy for Peanut Allergy (PMIT)
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00597675: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT00597675 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597675, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
Primary Outcome
After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE \>2 and \<15 AND skin prick test is \<5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Peanut OIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-03 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT00597675 record still lists
NCT00597675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00597675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00597675 about?
NCT00597675 is a clinical study titled "Oral Immunotherapy for Peanut Allergy (PMIT)". The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.
What is the current status of trial NCT00597675?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2007-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00597675?
The interventions under investigation include: Placebo (BIOLOGICAL), Peanut OIT (BIOLOGICAL).
Who is sponsoring clinical trial NCT00597675?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00597675's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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