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NCT00597727 · ClinicalTrials.gov registry record · Phase 2
A Study of Sublingual Immunotherapy in Peanut-allergic Children
A Phase 2 study of Food Hypersensitivity, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00597727: Completed Phase 2 study of Food Hypersensitivity, sponsored by University of North Carolina, Chapel Hill.
NCT00597727 is a Phase 2 study of Food Hypersensitivity that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants, below the 4,651-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597727, a Phase 2 study of Food Hypersensitivity, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.
Primary Outcome
Upon completion of 12 months of peanut SLIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCFC) to assess desensitization (an increase in reaction threshold while on therapy). A DBPCFC involves the ingestion of small increasing amounts of peanut up to a cumulative total amount. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 2500 mg peanut protein DBPCFC without developing symptoms after 12 mont
Conditions Studied
Interventions
- DRUG Peanut SLIT
- DRUG Placebo SLIT
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT00597727 record still lists
NCT00597727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 4,651-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Food Hypersensitivity appearing as the primary indexed condition, and to 2 interventions - of which Peanut SLIT is the first listed.
NCT00597727 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00597727 about?
NCT00597727 is a clinical study titled "A Study of Sublingual Immunotherapy in Peanut-allergic Children". The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.
What is the current status of trial NCT00597727?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-01. Estimated completion is 2016-03.
What conditions does trial NCT00597727 study?
This clinical trial studies the following conditions: Food Hypersensitivity.
What interventions are being tested in trial NCT00597727?
The interventions under investigation include: Peanut SLIT (DRUG), Placebo SLIT (DRUG).
Who is sponsoring clinical trial NCT00597727?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597727 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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