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NCT00732654 · ClinicalTrials.gov registry record · Phase 1
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
A Phase 1 study of Milk Allergy, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT00732654: Completed Phase 1 study of Milk Allergy, sponsored by Johns Hopkins University.
NCT00732654 is a Phase 1 study of Milk Allergy that has completed, run by Johns Hopkins University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00732654, a Phase 1 study of Milk Allergy, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
Primary Outcome
Cow's milk specific IgE was measured at baseline and after therapy (kUa/L)
Conditions Studied
Interventions
- DRUG Milk Protein Extract Immunotherapy goal of 4mg/day
- DRUG Milk Protein Extract Immunotherapy goal of 7mg/day
- DRUG Milk Powder Immunotherapy goal dose 2000 mg/day
- DRUG Milk Powder Immunotherapy goal dose 1000mg/day
Study Locations (2)
Maryland
- Johns Hopkins Hospital - Baltimore
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT00732654 record still lists
NCT00732654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Milk Allergy appearing as the primary indexed condition, and to 4 interventions - of which Milk Protein Extract Immunotherapy goal of 4mg/day is the first listed.
NCT00732654 reports a single indexed study location in Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00732654 about?
NCT00732654 is a clinical study titled "The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy". The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
What is the current status of trial NCT00732654?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-08. Estimated completion is 2012-06.
What conditions does trial NCT00732654 study?
This clinical trial studies the following conditions: Milk Allergy.
What interventions are being tested in trial NCT00732654?
The interventions under investigation include: Milk Protein Extract Immunotherapy goal of 4mg/day (DRUG), Milk Protein Extract Immunotherapy goal of 7mg/day (DRUG), Milk Powder Immunotherapy goal dose 2000 mg/day (DRUG), Milk Powder Immunotherapy goal dose 1000mg/day (DRUG).
Who is sponsoring clinical trial NCT00732654?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00732654 being conducted?
This trial has 2 study locations across Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00732654's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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