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Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Anaphylaxis Clinical Trial

Official title:
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children

Clinical Trial Summary

The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Clinical Trial Description

Eligibility criteria:

Age 6 - 16 yrs

- IgE-mediated milk allergy

- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms

Outcome measures:

- number of patients with successful desensitization (195 - 200 ml milk per day)

- number of patients with adverse events ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01361347
Study type Interventional
Source Tampere University Hospital
Contact
Status Completed
Phase Phase 4
Start date February 2008
Completion date December 2016
View Details
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