NCT01361347CompletedPhase 4
Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
Tampere University Hospital2 sites in 1 country28 target enrollmentStarted: February 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Tampere University Hospital
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability
Study Overview
Brief Summary
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IgE-mediated milk allergy
- •An immediately positive challenge test result to milk prior to inclusion
Exclusion Criteria
- •Not willing to participate
Outcomes
Primary Outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 12 months
Secondary Outcomes
- Number of participants drinking 2 dl/day of milk (success in desensitization)(12 months)
Investigators
Marita Paassilta
MD, PhD, Paediatric Allergist
Tampere University Hospital
Study Sites (2)
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