Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by (Responsible Party):
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00761527
First received: September 25, 2008
Last updated: January 27, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial Urticaria |
Drug: Desloratadine Syrup |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Syrup Among Filipino Pediatric Patients |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Number of Adverse Events Reported By Category After 14 Days of Treatment [ Time Frame: 15 Days ] [ Designated as safety issue: Yes ]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.
- Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment [ Time Frame: 15 Days ] [ Designated as safety issue: Yes ]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.
- Participant Global Tolerability Assessment [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Investigator Assessment of Clinical Efficacy [ Time Frame: Day 15 ] [ Designated as safety issue: No ]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.
| Enrollment: | 2980 |
| Study Start Date: | March 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Participants with allergic rhinitis or idiopathic urticaria
Outpatient pediatric participants (ages 6 months-11 years) in the Philippines with a diagnosis of allergic rhinitis or chronic idiopathic urticaria.
|
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:
Other Name: Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
|
Detailed Description:
Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.
Eligibility| Ages Eligible for Study: | 6 Months to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites in the Phillipines
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00761527 History of Changes |
| Other Study ID Numbers: | P05634 |
| Study First Received: | September 25, 2008 |
| Results First Received: | November 4, 2011 |
| Last Updated: | January 27, 2012 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Rhinitis, Allergic, Perennial Urticaria Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Skin Diseases, Vascular Skin Diseases Desloratadine |
Loratadine Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Antipruritics Dermatologic Agents Therapeutic Uses Anti-Allergic Agents |
ClinicalTrials.gov processed this record on June 18, 2013