Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00761527
Other study ID # P05634
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2008
Est. completion date May 2010

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 purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.


Description:

Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.


Recruitment information / eligibility

Status Completed
Enrollment 2980
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 6 Months to 11 Years
Eligibility Inclusion Criteria: - Outpatient pediatric participants, male or female, aged 6 months to 11 years - Diagnosis of allergic rhinitis or chronic idiopathic urticaria Exclusion Criteria: - Known hypersensitivity to desloratadine

Study Design


Intervention

Drug:
Desloratadine Syrup
Desloratadine (Aerius) Syrup; Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days: Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine) Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine) Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events Reported By Category After 14 Days of Treatment Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. 15 Days
Primary Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. 15 Days
Primary Participant Global Tolerability Assessment The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows:
Excellent
Very Good
Good
Fair
poor
Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented.
Day 15
Secondary Investigator Assessment of Clinical Efficacy Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15. Day 15
See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT00851344 - Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo Phase 2
Completed NCT00537355 - An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00501527 - Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense Phase 2
Completed NCT00422149 - Twin SUBLIVAC® Grasses Clinical Efficacy Study Phase 3
Completed NCT00542607 - Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis Phase 4
Completed NCT00605852 - Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects Phase 1
Active, not recruiting NCT05960266 - Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study Early Phase 1
Completed NCT02256553 - Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006) Phase 4
Completed NCT00932256 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients Phase 1
Completed NCT01007721 - Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season Phase 2
Completed NCT00901914 - Study of rBet v1 Tablets Phase 2
Completed NCT00384475 - A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413) Phase 3
Completed NCT00839189 - Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults Phase 1
Completed NCT00135629 - Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever Phase 3
Completed NCT04687059 - An Exploratory Study of PQ Grass 27600 SU Phase 2/Phase 3
Completed NCT00889460 - Safety and Tolerability Study of rBet v1 SLIT Tablets Phase 1
Completed NCT00396149 - Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1 Phase 1
Completed NCT00659594 - Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406) Phase 3
Completed NCT00127647 - An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327) Phase 3