Trial · NCT00761527
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
NCT00761527, Completed, Organon and Co; results first posted 2012-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634). Trials, record NCT00761527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
- NCT number
- NCT00761527
- Status
- Completed
- Enrollment
- 2,980 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Interventions
- Desloratadine Syrup
- First posted
- 2008-09-29
- Last updated
- 2022-02-09
- Results first posted
- 2012-03-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events Reported By Category After 14 Days of Treatment | 15 Days | 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. |
| Primary | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | 15 Days | 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. |
| Primary | Participant Global Tolerability Assessment | Day 15 | 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 | Investigator Assessment of Clinical Efficacy | Day 15 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events Reported By Category After 14 Days of Treatment | 15 Days | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup. | Adverse Events | NUMBER |
| PRIMARY | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | 15 Days | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup. | Participants | NUMBER |
| SECONDARY | Investigator Assessment of Clinical Efficacy | Day 15 | ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported. | Participants | NUMBER |
| PRIMARY | Participant Global Tolerability Assessment | Day 15 | The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Total Number of AEs | 26 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Mild AEs | 21 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Moderate AEs | 4 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Severe AEs | 1 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Treatment-related AEs | 20 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Mild Treatment-related AEs | 19 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Moderate Treatment-related AEs | 0 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Severe Treatment-related AEs | 1 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of SAEs | 1 | Adverse Events | |
| Number of Adverse Events Reported By Category After 14 Days of Treatment | Desloratadine (Aerius) Syrup | Number of Treatment-related SAEs | 0 | Adverse Events |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Desloratadine (Aerius) Syrup | 2,980 | |
| Overall Study | Received One Dose of Study Medication | Desloratadine (Aerius) Syrup | 2,978 | |
| Overall Study | COMPLETED | Desloratadine (Aerius) Syrup | 2,958 | |
| Overall Study | NOT COMPLETED | Desloratadine (Aerius) Syrup | 22 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Desloratadine (Aerius) Syrup | 1 | 2,978 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Desloratadine (Aerius) Syrup | ||
| Total, other adverse events | Desloratadine (Aerius) Syrup | 0 | 2,978 |
| Total, serious adverse events | Desloratadine (Aerius) Syrup | 1 | 2,978 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00761527/results?page=2