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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00963573
First received: August 20, 2009
Last updated: May 7, 2014
Last verified: May 2014

August 20, 2009
May 7, 2014
September 2003
November 2006   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00963573 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rhinitis
  • 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
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
Interventions:
  • Drug: Loratadine
  • Drug: Betamethasone
Mendoza de Morales T, Sánchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2006
November 2006   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00963573
P03428
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP