JPRN-jRCT2031230143
Active, not recruiting
Phase 3
A Phase III Study Evaluating Efficacy and Safety of Adrenaline of ARS-1 in Patients with Food Allergies
Kenya Morita0 sites15 target enrollmentJune 16, 2023
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kenya Morita
- Enrollment
- 15
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Between the ages of 4 and 55 years at IC
- •2\. Has body weight 15 kg or higher before OFC test at Day1
- •3\. Is scheduled for an inpatient oral food challenge test.
- •4\. Must have an oral food allergy that elicited symptoms of grade 2 or higher gastrointestinal, respiratory, or circulatory symptoms according to the Severity Classification of Organ Symptoms Induced by Anaphylaxis in the Anaphylaxis Guidelines of the Japanese Society of Allergology.
Exclusion Criteria
- •1\. Has prior nasal fractures, severe nasal injuries, history of nasal disorders, any nasal conditions that could interfere with nasal spray administration, abuse of nasal decongestants, or sleep apnea.
- •2\. Has used nasal drugs within 14 days from Day1\.
- •3\. Has mucosal inflammatory disorders (e.g., pemphigus or Sjogren's syndrome or fungal sinusitis).
- •4\. Known hypersensitivity to any compound in sympathomimetics or any compounds contained in investigational drugs (adrenaline, n\-dodecyl\-beta\-D\-maltoside, sodium edetate hydrate, benzalkonium chloride, sodium pyrosulfite) or other closely related compound.
Outcomes
Primary Outcomes
Not specified
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