CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Milk Protein Extract Immunotherapy goal of 4mg/day +3 moredrug
Likely dose
Milk Protein Extract Immunotherapy goal of 4mg/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00732654
NCT00732654Phase 2Completed
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The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy

Johns Hopkins University·interventional·Posted Aug 12, 2008·Updated May 15, 2017

In Brief

A Phase 2 clinical trial evaluating Milk Protein Extract Immunotherapy goal of 4mg/day, Milk Protein Extract Immunotherapy goal of 7mg/day, and 2 other interventions for Milk Allergy. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMilk Allergy
CountriesUnited States
CollaboratorsDuke University, Greer Laboratories

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2008
Enrollment StartAug 1, 2008
Primary CompletionJun 1, 2010
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.9 years ago

Interventions

Milk Protein Extract Immunotherapy goal of 4mg/daydrug

Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.

Milk Protein Extract Immunotherapy goal of 7mg/daydrug

Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.

Milk Powder Immunotherapy goal dose 2000 mg/daydrug

Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.

Milk Powder Immunotherapy goal dose 1000mg/daydrug

Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.