- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963573
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
April 20, 2015 updated by: Merck Sharp & Dohme LLC
Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children
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 treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: loratadine/betamethasone oral solution
loratadine/betamethasone oral solution (1 mg/0.05
mg/1 mL), at a dose of 10 mg/0.5 mg
|
loratadine/betamethasone oral solution (1 mg/0.05
mg/1 mL), at a dose of 10 mg/0.5 mg
Other Names:
loratadine/betamethasone oral solution (1 mg/0.05
mg/1 mL), at a dose of 10 mg/0.5 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children
Time Frame: Day 6 (Final visit)
|
Day 6 (Final visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 20, 2009
First Posted (Estimate)
August 21, 2009
Study Record Updates
Last Update Posted (Estimate)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Histamine H1 Antagonists, Non-Sedating
- Betamethasone
- Loratadine
Other Study ID Numbers
- P03428
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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