Trial · NCT00375713
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
NCT00375713, Phase 3, Completed, UCB Pharma; results first posted 2009-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema. Trials, record NCT00375713. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00375713
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
- NCT number
- NCT00375713
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 466 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Dermatitis, Eczema
- Interventions
- Levocetirizine, Cetirizine, Placebo-Levocetirizine, Placebo-Cetirizine, Standard topical steroid (1% hydrocortisone) ointment
- First posted
- 2006-09-13
- Last updated
- 2011-08-31
- Results first posted
- 2009-10-14
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Day 7 and 14 | A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None. |
| Secondary | Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period | Baseline and at endpoint during the 14 day treatment period | The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion. |
| Secondary | Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period | At endpoint during the 14 day treatment period | Duration of pruritus was categorized as follows: 3 if \> 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion. |
| Secondary | Global Improvement at Endpoint During the 14 Day Treatment Period | At endpoint during the 14 day treatment period | Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion. |
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 | Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Day 7 and 14 | The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors. | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period | Baseline and at endpoint during the 14 day treatment period | All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization. | Units on a scale | MEAN |
| SECONDARY | Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period | At endpoint during the 14 day treatment period | All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization. | Units on a scale | MEAN |
| SECONDARY | Global Improvement at Endpoint During the 14 Day Treatment Period | At endpoint during the 14 day treatment period | All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Levocetirizine | Responder | 131 | Participants | |
| Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Cetirizine | Responder | 134 | Participants | |
| Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Levocetirizine | Non-Responder | 37 | Participants | |
| Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). | Cetirizine | Non-Responder | 38 | Participants | |
| Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period | Levocetirizine | 1.15 | Standard Error 0.05 | Units on a scale | |
| Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period | Cetirizine | 1.21 | Standard Error 0.05 | Units on a scale | |
| Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period | Levocetirizine | 2.13 | Standard Error 0.05 | Units on a scale | |
| Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period | Cetirizine | 2.20 | Standard Error 0.05 | Units on a scale | |
| Global Improvement at Endpoint During the 14 Day Treatment Period | Levocetirizine | Marked improvement | 47 | Participants | |
| Global Improvement at Endpoint During the 14 Day Treatment Period | Cetirizine | Marked improvement | 52 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levocetirizine | 232 | |
| Overall Study | STARTED | Cetirizine | 234 | |
| Overall Study | COMPLETED | Levocetirizine | 212 | |
| Overall Study | COMPLETED | Cetirizine | 211 | |
| Overall Study | NOT COMPLETED | Levocetirizine | 20 | |
| Overall Study | NOT COMPLETED | Cetirizine | 23 |
Source ClinicalTrials.gov
Adverse events4
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 | Rhinitis | Respiratory, thoracic and mediastinal disorders | Levocetirizine | 0 | 209 | 0 |
| other | Rhinitis | Respiratory, thoracic and mediastinal disorders | Cetirizine | 5 | 214 | 5 |
| serious | Leukemia acute | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Levocetirizine | 1 | 209 | 1 |
| serious | Leukemia acute | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Cetirizine | 0 | 214 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levocetirizine | ||
| Total, all-cause mortality | Cetirizine | ||
| Total, other adverse events | Levocetirizine | 0 | 209 |
| Total, other adverse events | Cetirizine | 5 | 214 |
| Total, serious adverse events | Levocetirizine | 1 | 209 |
| Total, serious adverse events | Cetirizine | 0 | 214 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Levocetirizine vs Cetirizine: serious adverse events |
Source Trial comparisons
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/NCT00375713
GET https://conductscience.org/api/trials/v1/NCT00375713/registered