Clinical Trials Logo
  1. Home
  2. Rhinitis
  3. NCT00723736
  4. Details
NCT00723736 Clinical Trial

Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

Rhinitis Clinical Trial

Official title:
Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00723736
Other study ID # P04446
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2007
Est. completion date June 2008

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Description:

Pediatric patients aged 1-5 years

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender All
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria: - Patients with allergic rhinitis or chronic idiopathic urticaria - Aged 1-5 years old - Caregiver's consent to participate Exclusion Criteria: - Healthy individuals - Younger or older than the 1-5 year old age range

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Desloratadine
2.5 ml (1.25 mg) once daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Patients With Adverse Events An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. Follow-up visit at 3 - 5 weeks after treatment initiation
See also
  Status Clinical Trial Phase
Completed NCT02340130 - Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma Phase 2
Completed NCT02360072 - Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Completed NCT01118312 - Study of Asthma and Nasal Steroids Phase 4
Completed NCT00762567 - Phenylephrine Pediatric Pharmacokinetic Study Phase 1
Completed NCT00541255 - A Long-Term Examination of Asthma From Childhood Through Adolescence
Completed NCT00279916 - Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays Phase 3
Completed NCT00524836 - Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis Phase 3
Completed NCT00963573 - Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428) Phase 4
Completed NCT00521131 - Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites Phase 4
Completed NCT04132570 - A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution Phase 4
Completed NCT02784262 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis Phase 2
Terminated NCT02630472 - Topical Irrigation Therapy for CRS Phase 1/Phase 2
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02279706 - Korean Linguistic Adaptation of Rhinitis Controlled Assessment Test N/A
Completed NCT01971086 - Treatment With Rhinospray Plus in Patients With Acute Rhinitis in the Everyday Curative Routine in Hungary N/A
Completed NCT01771120 - Control and Burden of Asthma and Rhinitis N/A
Completed NCT01469234 - A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) Phase 4
Withdrawn NCT01177852 - Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis Phase 3
Completed NCT00724698 - Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria
Completed NCT02879929 - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction N/A