Anaphylaxis Clinical Trial
Official title:
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Verified date | January 2017 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 16 Years |
Eligibility |
Inclusion Criteria: - IgE-mediated milk allergy - An immediately positive challenge test result to milk prior to inclusion Exclusion Criteria: - Not willing to participate |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital, Allergy Centre | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events as a measure of safety and tolerability | 12 months | Yes | |
Secondary | Number of participants drinking 2 dl/day of milk (success in desensitization) | 12 months | Yes |
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