Status:
COMPLETED
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rhinitis
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate trea...
Eligibility Criteria
Inclusion
- Clinical diagnosis of perennial allergic rhinitis.
- Age \>= 6 years old and \<= 12 years old.
- Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
- Symptoms total score at admission \>= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
- Number of symptoms: At least three.
Exclusion
- Age \< 6 years old or \> 12 years old.
- Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
- Presence of systemic fungal infections.
- Conscience or behavioral disturbances.
- Current oral or parenteral steroid treatment.
- Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
- Known hypersensitivity to any of the study pharmacological combination components.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00963573
Start Date
September 1 2003
End Date
November 1 2006
Last Update
April 21 2015
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