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NCT01084174 · ClinicalTrials.gov registry record · Phase 1
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy
A Phase 1 study of Food Hypersensitivity and Peanut Hypersensitivity, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01084174: Completed Phase 1 study of Food Hypersensitivity and Peanut Hypersensitivity, sponsored by Johns Hopkins University.
NCT01084174 is a Phase 1 study of Food Hypersensitivity and Peanut Hypersensitivity that has completed, run by Johns Hopkins University. The registered enrollment target is 21 participants, below the 4,658-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01084174, a Phase 1 study of Food Hypersensitivity and Peanut Hypersensitivity, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
Primary Outcome
Peanut desensitization was defined as a greater than 10-fold increase in oral food challenge (OFC) threshold after 12 months of therapy.
Conditions Studied
Interventions
- DRUG Peanut powder
- DRUG Peanut extract
- DRUG Placebo extract
- DRUG Placebo powder
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT01084174 record still lists
NCT01084174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 4,658-participant average among 5 other Food Hypersensitivity trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Food Hypersensitivity appearing as the primary indexed condition, and to 4 interventions - of which Peanut powder is the first listed.
NCT01084174 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01084174 about?
NCT01084174 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Sublingual/Oral Immunotherapy for the Treatment of Peanut Allergy". The purpose of this study is to explore the safety and efficacy of a sublingual (under the tongue) immunotherapy (SLIT) dosing regimen and an oral immunotherapy (OIT) regimen in inducing desensitization and long term tolerance in children with persistent peanut allergy.
What is the current status of trial NCT01084174?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2010-03. Estimated completion is 2013-01.
What conditions does trial NCT01084174 study?
This clinical trial studies the following conditions: Food Hypersensitivity, Peanut Hypersensitivity, Immediate Hypersensitivity.
What interventions are being tested in trial NCT01084174?
The interventions under investigation include: Peanut powder (DRUG), Peanut extract (DRUG), Placebo extract (DRUG), Placebo powder (DRUG).
Who is sponsoring clinical trial NCT01084174?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01084174 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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