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Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00963573
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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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 treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.

Condition or disease Intervention/treatment Phase
Rhinitis Drug: Loratadine Drug: Betamethasone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Drug: Loratadine
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Other Name: SCH 029851

Drug: Betamethasone
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Other Name: SCH 029851


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00963573    
Other Study ID Numbers: P03428
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Betamethasone
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action