Trial · NCT00536380
Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)
NCT00536380, Phase 4, Completed, Organon and Co; results first posted 2010-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849). Trials, record NCT00536380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00536380
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)
- NCT number
- NCT00536380
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 314 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Chronic Idiopathic Urticaria
- Interventions
- 5-mg Desloratadine, 10-mg Desloratadine, 20-mg Desloratadine
- First posted
- 2007-09-27
- Last updated
- 2024-05-23
- Results first posted
- 2010-05-03
- Limitations and caveats
Due to poor enrollment (even after extending the enrollment period), only 314 participants (not 600 participants) were randomized to the study and hence the study was inconclusive due to the lacking of statistical power and robustness.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | Baseline and 4 treatment weeks | The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was "reflective", covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | Baseline and 4 treatment weeks | Intent to treat population | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 5-mg Desloratadine | Change from Baseline in UAS | -1.0 | Standard Error 0.12 | Units on a scale |
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 20-mg Desloratadine | Change from Baseline in UAS | -1.0 | Standard Error 0.12 | Units on a scale |
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 10-mg Desloratadine | Change from Baseline in UAS | -1.1 | Standard Error 0.12 | Units on a scale |
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 5-mg Desloratadine | Baseline UAS (mean +/- standard deviation) | 2.9 | Standard Error 0.82 | Units on a scale |
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 20-mg Desloratadine | Baseline UAS (mean +/- standard deviation) | 2.8 | Standard Error 0.74 | Units on a scale |
| Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg | 10-mg Desloratadine | Baseline UAS (mean +/- standard deviation) | 2.9 | Standard Error 0.77 | Units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5-mg Desloratadine | 106 | |
| Overall Study | STARTED | 10-mg Desloratadine | 104 | |
| Overall Study | STARTED | 20-mg Desloratadine | 104 | |
| Overall Study | COMPLETED | 5-mg Desloratadine | 94 | |
| Overall Study | COMPLETED | 10-mg Desloratadine | 95 | |
| Overall Study | COMPLETED | 20-mg Desloratadine | 94 | |
| Overall Study | NOT COMPLETED | 5-mg Desloratadine | 12 | |
| Overall Study | NOT COMPLETED | 10-mg Desloratadine | 9 | |
| Overall Study | NOT COMPLETED | 20-mg Desloratadine | 10 |
Source ClinicalTrials.gov
Adverse events9
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 |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | 5-mg Desloratadine | 5 | 106 | 6 |
| other | Headache | Nervous system disorders | 10-mg Desloratadine | 4 | 104 | 5 |
| other | Headache | Nervous system disorders | 20-mg Desloratadine | 6 | 104 | 9 |
| serious | Pneumonia | Infections and infestations | 5-mg Desloratadine | 0 | 106 | 0 |
| serious | Pneumonia | Infections and infestations | 10-mg Desloratadine | 1 | 104 | 1 |
| serious | Pneumonia | Infections and infestations | 20-mg Desloratadine | 0 | 104 | 0 |
| serious | Urticaria | Skin and subcutaneous tissue disorders | 5-mg Desloratadine | 0 | 106 | 0 |
| serious | Urticaria | Skin and subcutaneous tissue disorders | 10-mg Desloratadine | 0 | 104 | 0 |
| serious | Urticaria | Skin and subcutaneous tissue disorders | 20-mg Desloratadine | 1 | 104 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-mg Desloratadine | ||
| Total, all-cause mortality | 10-mg Desloratadine | ||
| Total, all-cause mortality | 20-mg Desloratadine | ||
| Total, other adverse events | 5-mg Desloratadine | 5 | 106 |
| Total, other adverse events | 10-mg Desloratadine | 4 | 104 |
| Total, other adverse events | 20-mg Desloratadine | 6 | 104 |
| Total, serious adverse events | 5-mg Desloratadine | 0 | 106 |
| Total, serious adverse events | 10-mg Desloratadine | 1 | 104 |
| Total, serious adverse events | 20-mg Desloratadine | 1 | 104 |
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.
GET https://conductscience.org/api/trials/v1/NCT00536380
GET https://conductscience.org/api/trials/v1/NCT00536380/registered