Trial | Outcome |
NCT00152464 (10) [back to overview] | Percentage of Days With Symptoms of Nocturnal Cough |
NCT00152464 (10) [back to overview] | Percentage of Subjects Using Medication for Atopic Dermatitis |
NCT00152464 (10) [back to overview] | Number of Episodes of Urticaria Per Subject |
NCT00152464 (10) [back to overview] | Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough |
NCT00152464 (10) [back to overview] | Percentage of Days With Symptoms of Wheezing |
NCT00152464 (10) [back to overview] | Percentage of Subjects With Urticaria |
NCT00152464 (10) [back to overview] | Time to Onset of Asthma During the Treatment Period |
NCT00152464 (10) [back to overview] | Percentage of Days of Use of Asthma Medication |
NCT00152464 (10) [back to overview] | Percentage of Days of Use of Medication for Atopic Dermatitis |
NCT00152464 (10) [back to overview] | Percentage of Subjects Using Asthma Medication |
NCT00160680 (14) [back to overview] | Mean Weekly Individual Symptoms Scores During the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period |
NCT00160680 (14) [back to overview] | Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period |
NCT00264303 (6) [back to overview] | Mean Score for Pruritus Duration Over the Four Weeks of Treatment |
NCT00264303 (6) [back to overview] | Mean Pruritus Severity Score Over the Four Weeks of Treatment |
NCT00264303 (6) [back to overview] | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment |
NCT00264303 (6) [back to overview] | Mean Pruritus Severity Score Over the First Week of Treatment |
NCT00264303 (6) [back to overview] | Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment |
NCT00264303 (6) [back to overview] | Mean Score for Pruritus Duration Over the First Week of Treatment |
NCT00291642 (9) [back to overview] | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I |
NCT00291642 (9) [back to overview] | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II) |
NCT00291642 (9) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I |
NCT00291642 (9) [back to overview] | Change From Baseline in the MSC Score Over Period II |
NCT00291642 (9) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II |
NCT00291642 (9) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II) |
NCT00291642 (9) [back to overview] | Change From Baseline in the Individual Symptom Scores Over Period I |
NCT00291642 (9) [back to overview] | Change From Baseline in the Individual Symptom Scores Over Period II |
NCT00291642 (9) [back to overview] | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II) |
NCT00295022 (26) [back to overview] | Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season |
NCT00295022 (26) [back to overview] | Onset of Action During Period I |
NCT00295022 (26) [back to overview] | Global Satisfaction of the Subjects at the End of Period III |
NCT00295022 (26) [back to overview] | Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) |
NCT00295022 (26) [back to overview] | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III |
NCT00295022 (26) [back to overview] | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II |
NCT00295022 (26) [back to overview] | Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I |
NCT00295022 (26) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) |
NCT00295022 (26) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III |
NCT00295022 (26) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II |
NCT00295022 (26) [back to overview] | Change From Baseline in the Individual Symptom Scores Over Period I |
NCT00295022 (26) [back to overview] | Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) |
NCT00295022 (26) [back to overview] | Change From Baseline in the MSC Score Over Period III |
NCT00295022 (26) [back to overview] | Change From Baseline in the MSC Score Over Period II |
NCT00295022 (26) [back to overview] | Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I |
NCT00295022 (26) [back to overview] | Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I |
NCT00295022 (26) [back to overview] | Variability of Action From Baseline in the MSC Score Over Period III |
NCT00295022 (26) [back to overview] | Variability of Action From Baseline in the MSC Score Over Period II |
NCT00295022 (26) [back to overview] | Intensity of Action From Baseline in the MSC Score Over Period III |
NCT00295022 (26) [back to overview] | Intensity of Action From Baseline in the MSC Score Over Period II |
NCT00295022 (26) [back to overview] | Intensity of Action From Baseline in the MSC Score Over Period I |
NCT00295022 (26) [back to overview] | Variability of Action From Baseline in the MSC Score Over Period I |
NCT00295022 (26) [back to overview] | Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) |
NCT00295022 (26) [back to overview] | Change From Baseline in the Individual Symptom Scores Over Period III |
NCT00295022 (26) [back to overview] | Change From Baseline in the Individual Symptom Scores Over Period II |
NCT00295022 (26) [back to overview] | Time to First Feeling of Improvement During Period I |
NCT00359138 (1) [back to overview] | Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment |
NCT00375713 (4) [back to overview] | Global Improvement at Endpoint During the 14 Day Treatment Period |
NCT00375713 (4) [back to overview] | Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). |
NCT00375713 (4) [back to overview] | Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period |
NCT00375713 (4) [back to overview] | Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval |
NCT00619801 (13) [back to overview] | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) |
NCT00619801 (13) [back to overview] | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST) |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval |
NCT00619801 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) |
NCT00621959 (2) [back to overview] | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) |
NCT00621959 (2) [back to overview] | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score |
NCT00628108 (13) [back to overview] | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) |
NCT00628108 (13) [back to overview] | Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT) |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST) |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval |
NCT00628108 (13) [back to overview] | Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin |
NCT00653224 (90) [back to overview] | Total Nasal Symptom Score (TNSS) Over the Second Week |
NCT00653224 (90) [back to overview] | Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Total Ocular Symptom Score (TOSS) Over the First Week |
NCT00653224 (90) [back to overview] | Total Ocular Symptom Score (TOSS) Over the Second Week |
NCT00653224 (90) [back to overview] | Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period |
NCT00653224 (90) [back to overview] | Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period |
NCT00653224 (90) [back to overview] | Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2 |
NCT00653224 (90) [back to overview] | Ocular Pruritus Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1 |
NCT00653224 (90) [back to overview] | Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2 |
NCT00653224 (90) [back to overview] | Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Nasal Congestion Score Over the First Week |
NCT00653224 (90) [back to overview] | Nasal Congestion Score Over the Second Week |
NCT00653224 (90) [back to overview] | Nasal Congestion Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Nasal Pruritus Score Over the First Week |
NCT00653224 (90) [back to overview] | Nasal Pruritus Score Over the Second Week |
NCT00653224 (90) [back to overview] | Nasal Pruritus Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Ocular Itching/Burning Score Over the First Week |
NCT00653224 (90) [back to overview] | Ocular Itching/Burning Score Over the Second Week |
NCT00653224 (90) [back to overview] | Ocular Itching/Burning Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Ocular Pruritus Score Over the First Week |
NCT00653224 (90) [back to overview] | Ocular Pruritus Score Over the Second Week |
NCT00653224 (90) [back to overview] | Ocular Redness Score Over the First Week |
NCT00653224 (90) [back to overview] | Ocular Redness Score Over the Second Week |
NCT00653224 (90) [back to overview] | Ocular Redness Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Ocular Tearing/Watering Score Over the First Week |
NCT00653224 (90) [back to overview] | Ocular Tearing/Watering Score Over the Second Week |
NCT00653224 (90) [back to overview] | Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Post-nasal Drip Score Over the First Week |
NCT00653224 (90) [back to overview] | Post-nasal Drip Score Over the Second Week |
NCT00653224 (90) [back to overview] | Post-nasal Drip Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Rhinorrhea Score Over the First Week |
NCT00653224 (90) [back to overview] | Rhinorrhea Score Over the Second Week |
NCT00653224 (90) [back to overview] | Rhinorrhea Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Sneezing Score Over the First Week |
NCT00653224 (90) [back to overview] | Sneezing Score Over the Second Week |
NCT00653224 (90) [back to overview] | Sneezing Score Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Total 4 Symptoms Score (T4SS) Over the First Week |
NCT00653224 (90) [back to overview] | Total 4 Symptoms Score (T4SS) Over the Second Week |
NCT00653224 (90) [back to overview] | Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days) |
NCT00653224 (90) [back to overview] | Total 5 Symptoms Score (T5SS) Over the First Week |
NCT00653224 (90) [back to overview] | Total 5 Symptoms Score (T5SS) Over the Second Week |
NCT00653224 (90) [back to overview] | Total Nasal Symptom Score (TNSS) Over the First Week |
NCT00826943 (3) [back to overview] | Modified Epworth Sleepiness Scale |
NCT00826943 (3) [back to overview] | Likert Score Rating Global Sedation |
NCT00826943 (3) [back to overview] | Total Four Symptom Scores (Allergy Symptoms) |
NCT00884325 (2) [back to overview] | Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4 |
NCT00884325 (2) [back to overview] | Pruritus VAS Scores at Baseline, Week 2 and Week 4 |
NCT01392859 (1) [back to overview] | Characterize Contribution of Histamine in Children With Asthma |
NCT01563081 (5) [back to overview] | Cmax and Cmin of Levocetirizine in Plasma |
NCT01563081 (5) [back to overview] | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal |
NCT01563081 (5) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) |
NCT01563081 (5) [back to overview] | Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression |
NCT01563081 (5) [back to overview] | Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator |
NCT01586091 (3) [back to overview] | Flaire Diameter (mm) |
NCT01586091 (3) [back to overview] | Pruritus as Assessed by the VAS Score |
NCT01586091 (3) [back to overview] | Wheal Volume (cm3) |
NCT01722162 (3) [back to overview] | Progression Free Survival (Arm A) |
NCT01722162 (3) [back to overview] | Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events |
NCT01722162 (3) [back to overview] | Progression Free Survival (Arm B) |
NCT03555890 (64) [back to overview] | Part 2: Number of Participants With AEs and SAEs |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in SBP and DBP |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Platelet Count and White Blood Cell Count |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Heart Rate (ECG) |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Heart Rate |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Body Temperature |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Albumin and Total Protein Levels |
NCT03555890 (64) [back to overview] | Part 1: Urine Specific Gravity |
NCT03555890 (64) [back to overview] | Part 1: Urine Potential of Hydrogen (pH) |
NCT03555890 (64) [back to overview] | Part 1: Number of Participants With Urinalysis Results by Dipstick Method |
NCT03555890 (64) [back to overview] | Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Platelet Count and White Blood Cell Count |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG]) |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Heart Rate |
NCT03555890 (64) [back to overview] | Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Body Temperature |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Albumin and Total Protein Levels |
NCT03555890 (64) [back to overview] | Part 2: Vz/F of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: Tmax of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: t1/2 of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: MRT of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: Kel (lambda_z) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: Cmax of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: CL/F of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Reticulocytes |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Red Blood Cell Count |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Mean Corpuscle Volume |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Mean Corpuscle Hemoglobin |
NCT03555890 (64) [back to overview] | Part 2: Change From Baseline in Amylase Levels |
NCT03555890 (64) [back to overview] | Part 2: Change Form Baseline in Hematocrit |
NCT03555890 (64) [back to overview] | Part 2: AUC(0-t) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 2: %AUCex of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Mean Residence Time (MRT) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Reticulocytes |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Red Blood Cell Count |
NCT03555890 (64) [back to overview] | Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels |
NCT03555890 (64) [back to overview] | Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine |
NCT03555890 (64) [back to overview] | Part 1: Change Form Baseline in Hematocrit |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Amylase Levels |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Mean Corpuscle Hemoglobin |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Mean Corpuscle Volume |
NCT03555890 (64) [back to overview] | Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels |
NCT03555890 (64) [back to overview] | Part 2: Urine Specific Gravity |
NCT03555890 (64) [back to overview] | Part 2: Urine Potential of Hydrogen (pH) |
NCT03555890 (64) [back to overview] | Part 2: Number of Participants With Urinalysis Results by Dipstick Method |
NCT03555890 (64) [back to overview] | Part 2: AUC(0-inf) of Levocetirizine |
Percentage of Days With Symptoms of Nocturnal Cough
The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | percentage of days (Mean) |
---|
Placebo (PBO) | 2.72 |
Levocetirizine (LCTZ) | 2.33 |
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Percentage of Subjects Using Medication for Atopic Dermatitis
The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics (NCT00152464)
Timeframe: During the treatment period (18 months)
,
Intervention | percentage of subjects (Number) |
---|
| Topical corticosteroids | Local Steroids Class A, NSAI creams, tar | Local Steroids Class B | Local Steroids Class C | Topical tacrolimus | Topical pimecrolimus | Systemic H1 anti-histamines | Local antibiotics or antiseptics |
---|
Levocetirizine (LCTZ) | 63.9 | 33.3 | 27.1 | 37.3 | 1.2 | 5.5 | 19.6 | 11.0 |
Placebo (PBO) | 61.6 | 31.4 | 28.6 | 33.7 | 0.8 | 2.4 | 22.0 | 12.9 |
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Number of Episodes of Urticaria Per Subject
Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | Number of episodes (Mean) |
---|
Placebo (PBO) | 1.71 |
Levocetirizine (LCTZ) | 0.71 |
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Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms. (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | percentage of days (Mean) |
---|
Placebo (PBO) | 3.5 |
Levocetirizine (LCTZ) | 2.85 |
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Percentage of Days With Symptoms of Wheezing
The caring person was to note on the diary card each each wheezing event occurring at any time. (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | percentage of days (Mean) |
---|
Placebo (PBO) | 1.31 |
Levocetirizine (LCTZ) | 0.88 |
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Percentage of Subjects With Urticaria
Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger. (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | percentage of participants (Number) |
---|
Placebo (PBO) | 41.6 |
Levocetirizine (LCTZ) | 27.5 |
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Time to Onset of Asthma During the Treatment Period
"The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma.~Instead of the median the first Quartile is reported since the median (50%) was not reached." (NCT00152464)
Timeframe: During the treatment period (18 months)
Intervention | months (Median) |
---|
Placebo (PBO) | NA |
Levocetirizine (LCTZ) | NA |
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Percentage of Days of Use of Asthma Medication
The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists (NCT00152464)
Timeframe: During the treatment period (18 months)
,
Intervention | percentage of days (Mean) |
---|
| Beta 2 Mimetics | Cromoglycates | Inhaled Corticoids | Systemic Corticoids | Leukotriene antagonists |
---|
Levocetirizine (LCTZ) | 1.37 | 0.09 | 1.98 | 0.13 | 0.34 |
Placebo (PBO) | 2.36 | 0.03 | 3.60 | 0.31 | 0.30 |
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Percentage of Days of Use of Medication for Atopic Dermatitis
The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics (NCT00152464)
Timeframe: During the treatment period (18 months)
,
Intervention | percentage of days (Mean) |
---|
| Topical corticosteroids | LSC A, NSAI creams, tar | LSC B | LSC C | Topical tacrolimus | Topical pimecrolimus | Systemic H1 a-h | Local ABs or antiseptics |
---|
Levocetirizine (LCTZ) | 31.84 | 18.64 | 12.30 | 8.27 | 0.02 | 0.31 | 1.95 | 2.63 |
Placebo (PBO) | 32.42 | 15.40 | 14.23 | 9.82 | 0.36 | 0.52 | 3.80 | 2.99 |
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Percentage of Subjects Using Asthma Medication
The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists (NCT00152464)
Timeframe: During the treatment period (18 months)
,
Intervention | percentage of participants (Number) |
---|
| Beta 2 Mimetics | Cromoglycates | Inhaled Corticoids | Systemic Corticoids | Leukotriene antagonists |
---|
Levocetirizine (LCTZ) | 33.3 | 1.2 | 15.3 | 12.5 | 3.5 |
Placebo (PBO) | 33.3 | 0.8 | 18.8 | 18.4 | 2.7 |
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Mean Weekly Individual Symptoms Scores During the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During the treatment period until week 24
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 0.82 | 0.80 | 0.71 | 0.55 | 0.87 |
On Demand Treatment (ODT) | 0.94 | 0.80 | 0.74 | 0.68 | 1.08 |
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Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 6 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 0.61 | 0.57 | 0.59 | 0.36 | 0.82 |
On Demand Treatment (ODT) | 1.11 | 1.00 | 0.84 | 0.69 | 1.15 |
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Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 5 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 0.51 | 0.51 | 0.44 | 0.27 | 0.63 |
On Demand Treatment (ODT) | 1.00 | 0.93 | 0.77 | 0.63 | 1.08 |
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Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 4 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 0.78 | 0.69 | 0.60 | 0.44 | 0.75 |
On Demand Treatment (ODT) | 0.85 | 0.72 | 0.59 | 0.53 | 1.07 |
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Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 3 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 0.82 | 0.84 | 0.74 | 0.61 | 0.87 |
On Demand Treatment (ODT) | 0.81 | 0.66 | 0.53 | 0.60 | 0.91 |
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Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 2 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 1.20 | 1.14 | 0.98 | 0.77 | 1.03 |
On Demand Treatment (ODT) | 0.87 | 0.80 | 0.75 | 0.77 | 1.04 |
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Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
"Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.~The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity." (NCT00160680)
Timeframe: During month 1 of the 6 months treatment period
,
Intervention | units on a scale (Least Squares Mean) |
---|
| Sneezing Score | Rhinorrhea Score | Nasal Pruritus Score | Ocular Pruritus Score | Nasal Congestion Score |
---|
Continuous Treatment (CT) | 1.31 | 1.33 | 1.06 | 0.90 | 1.25 |
On Demand Treatment (ODT) | 1.12 | 0.93 | 0.97 | 0.86 | 1.25 |
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Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During the treatment period until week 24
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 2.89 |
On Demand Treatment (ODT) | 3.15 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 6 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 2.19 |
On Demand Treatment (ODT) | 3.64 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 5 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 1.74 |
On Demand Treatment (ODT) | 3.31 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 3 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 2.98 |
On Demand Treatment (ODT) | 2.58 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 2 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 4.04 |
On Demand Treatment (ODT) | 3.14 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 1 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 4.55 |
On Demand Treatment (ODT) | 3.83 |
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Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease. (NCT00160680)
Timeframe: During month 4 of the 6 months treatment period
Intervention | units on a scale (Least Squares Mean) |
---|
Continuous Treatment (CT) | 2.47 |
On Demand Treatment (ODT) | 2.67 |
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Mean Score for Pruritus Duration Over the Four Weeks of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 0.93 |
Desloratadine 5 mg | 1.05 |
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Mean Pruritus Severity Score Over the Four Weeks of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 0.86 |
Desloratadine 5 mg | 0.99 |
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Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 1st week of treatment. (NCT00264303)
Timeframe: over the first week of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 1.98 |
Desloratadine 5 mg | 2.23 |
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Mean Pruritus Severity Score Over the First Week of Treatment
Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment. (NCT00264303)
Timeframe: over the first week of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 1.02 |
Desloratadine 5 mg | 1.18 |
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Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or <=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or >50 wheals/24 h). Mean is averaged over the 4 weeks of treatment. (NCT00264303)
Timeframe: over the four weeks of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 1.71 |
Desloratadine 5 mg | 1.88 |
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Mean Score for Pruritus Duration Over the First Week of Treatment
The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment. (NCT00264303)
Timeframe: over the first week of treatment
Intervention | Units on a scale (Least Squares Mean) |
---|
Levocetirizine 5 mg | 1.08 |
Desloratadine 5 mg | 1.24 |
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Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.80 |
Levocetirizine (LCTZ) 2.5 mg | -7.15 |
Levocetirizine (LCTZ) 5 mg | -7.05 |
Cetirizine (CTZ) 5 mg | -7.93 |
Cetirizine (CTZ) 10 mg | -7.54 |
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Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline to Day 2
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.61 |
Levocetirizine (LCTZ) 2.5 mg | -6.80 |
Levocetirizine (LCTZ) 5 mg | -7.10 |
Cetirizine (CTZ) 5 mg | -7.43 |
Cetirizine (CTZ) 10 mg | -7.72 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -6.55 |
Levocetirizine (LCTZ) 2.5 mg | -11.33 |
Levocetirizine (LCTZ) 5 mg | -11.27 |
Cetirizine (CTZ) 5 mg | -12.71 |
Cetirizine (CTZ) 10 mg | -11.74 |
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Change From Baseline in the MSC Score Over Period II
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.50 |
Levocetirizine (LCTZ) 2.5 mg | -6.35 |
Levocetirizine (LCTZ) 5 mg | -7.07 |
Cetirizine (CTZ) 5 mg | -6.78 |
Cetirizine (CTZ) 10 mg | -7.92 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -5.73 |
Levocetirizine (LCTZ) 2.5 mg | -10.25 |
Levocetirizine (LCTZ) 5 mg | -11.03 |
Cetirizine (CTZ) 5 mg | -10.73 |
Cetirizine (CTZ) 10 mg | -12.14 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline to Day 2
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -6.10 |
Levocetirizine (LCTZ) 2.5 mg | -10.86 |
Levocetirizine (LCTZ) 5 mg | -11.22 |
Cetirizine (CTZ) 5 mg | -11.84 |
Cetirizine (CTZ) 10 mg | -11.92 |
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Change From Baseline in the Individual Symptom Scores Over Period I
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
,,,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Nose Blow Score | Sneezes Score | Watery Eyes Score |
---|
Cetirizine (CTZ) 10 mg | -1.04 | -1.10 | -1.10 | -1.96 | -1.23 | -1.07 |
Cetirizine (CTZ) 5 mg | -1.17 | -1.28 | -1.24 | -1.92 | -1.22 | -1.13 |
Levocetirizine (LCTZ) 2.5 mg | -1.01 | -1.03 | -1.15 | -1.87 | -1.15 | -0.94 |
Levocetirizine (LCTZ) 5 mg | -0.95 | -1.09 | -1.06 | -1.82 | -1.07 | -1.08 |
Placebo (PBO) | -0.60 | -0.66 | -0.65 | -0.98 | -0.37 | -0.56 |
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Change From Baseline in the Individual Symptom Scores Over Period II
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
,,,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Nose Blow Score | Sneezes Score | Watery Eyes Score |
---|
Cetirizine (CTZ) 10 mg | -1.10 | -1.24 | -1.21 | -2.02 | -1.38 | -0.93 |
Cetirizine (CTZ) 5 mg | -0.95 | -1.13 | -0.90 | -1.78 | -1.19 | -0.83 |
Levocetirizine (LCTZ) 2.5 mg | -0.86 | -1.00 | -0.91 | -1.61 | -1.18 | -0.78 |
Levocetirizine (LCTZ) 5 mg | -0.94 | -1.11 | -0.96 | -1.84 | -1.33 | -0.91 |
Placebo (PBO) | -0.62 | -0.57 | -0.58 | -1.00 | -0.48 | -0.30 |
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Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00291642)
Timeframe: Baseline to Day 2
,,,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Nose Blow Score | Sneezes Score | Watery Eyes Score |
---|
Cetirizine (CTZ) 10 mg | -1.06 | -1.16 | -1.15 | -1.99 | -1.31 | -1.01 |
Cetirizine (CTZ) 5 mg | -1.07 | -1.21 | -1.09 | -1.86 | -1.21 | -1.00 |
Levocetirizine (LCTZ) 2.5 mg | -0.94 | -1.02 | -1.05 | -1.75 | -1.17 | -0.87 |
Levocetirizine (LCTZ) 5 mg | -0.95 | -1.10 | -1.02 | -1.83 | -1.19 | -1.01 |
Placebo (PBO) | -0.59 | -0.61 | -0.60 | -0.98 | -0.41 | -0.44 |
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Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
"At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: Do you want to take the same treatment during the next pollen season? (yes or no)." (NCT00295022)
Timeframe: At the end of Period III (Day 2)
Intervention | percentage of participants (Number) |
---|
Placebo (PBO) | 23.1 |
Levocetirizine (LCTZ) | 49.4 |
Montelukast (MLKT) | 32.9 |
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Onset of Action During Period I
The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time. (NCT00295022)
Timeframe: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | hours (Number) |
---|
Placebo (PBO) | NA |
Levocetirizine (LCTZ) | 1.5 |
Montelukast (MLKT) | 1.5 |
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Global Satisfaction of the Subjects at the End of Period III
Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied). (NCT00295022)
Timeframe: At the end of Period III (Day 2)
Intervention | units on a scale (Mean) |
---|
Placebo (PBO) | 32.42 |
Levocetirizine (LCTZ) | 53.94 |
Montelukast (MLKT) | 41.80 |
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Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -5.92 |
Levocetirizine (LCTZ) | -12.21 |
Montelukast (MLKT) | -9.28 |
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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -6.35 |
Levocetirizine (LCTZ) | -14.18 |
Montelukast (MLKT) | -10.39 |
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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -2.65 |
Levocetirizine (LCTZ) | -9.97 |
Montelukast (MLKT) | -5.47 |
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Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -6.57 |
Levocetirizine (LCTZ) | -11.15 |
Montelukast (MLKT) | -9.65 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -5.53 |
Levocetirizine (LCTZ) | -11.54 |
Montelukast (MLKT) | -8.68 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -5.91 |
Levocetirizine (LCTZ) | -13.39 |
Montelukast (MLKT) | -9.73 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -2.45 |
Levocetirizine (LCTZ) | -9.54 |
Montelukast (MLKT) | -5.12 |
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Change From Baseline in the Individual Symptom Scores Over Period I
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Postnasal Drip Score | Watery Eyes Score | Itchy Eyes/Ears Score | Itchy Throat Score | Cough Score | Sneezes Score | Nose Blows Score | Nasal Congestion Score |
---|
Levocetirizine (LCTZ) | -0.89 | -0.93 | -0.93 | -0.99 | -0.94 | -1.14 | -1.00 | -0.81 | -1.07 | -1.77 | -0.62 |
Montelukast (MLKT) | -0.86 | -0.85 | -0.87 | -0.89 | -0.82 | -0.90 | -0.85 | -0.71 | -0.68 | -1.59 | -0.64 |
Placebo (PBO) | -0.55 | -0.52 | -0.53 | -0.65 | -0.58 | -0.69 | -0.66 | -0.71 | -0.28 | -1.03 | -0.41 |
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Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.16 |
Levocetirizine (LCTZ) | -7.37 |
Montelukast (MLKT) | -5.48 |
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Change From Baseline in the MSC Score Over Period III
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.50 |
Montelukast (MLKT) | -8.62 |
Levocetirizine (LCTZ) | -6.19 |
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Change From Baseline in the MSC Score Over Period II
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -1.22 |
Levocetirizine (LCTZ) | -6.35 |
Montelukast (MLKT) | -3.24 |
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Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
"Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:~Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -3.46 |
Levocetirizine (LCTZ) | -6.58 |
Montelukast (MLKT) | -5.65 |
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Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
"The TSC score was calculated as the sum of the following 10 individual symptom scores:~runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.~Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo (PBO) | -6.16 |
Levocetirizine (LCTZ) | -10.53 |
Montelukast (MLKT) | -9.01 |
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Variability of Action From Baseline in the MSC Score Over Period III
"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | 20%-35% | 35%-50% | 50%-65% | 65%-80% | >=80% |
---|
Levocetirizine (LCTZ) | 16.7 | 17.9 | 13.5 | 14.1 | 17.9 | 19.9 |
Montelukast (MLKT) | 31.8 | 14.6 | 17.2 | 17.2 | 14.6 | 4.6 |
Placebo (PBO) | 48.1 | 21.2 | 15.4 | 3.8 | 8.7 | 2.9 |
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Variability of Action From Baseline in the MSC Score Over Period II
"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | 20%-35% | 35%-50% | 50%-65% | 65%-80% | >=80% |
---|
Levocetirizine (LCTZ) | 32.1 | 19.2 | 12.2 | 17.3 | 10.3 | 9.0 |
Montelukast (MLKT) | 53.6 | 16.6 | 17.2 | 6.6 | 3.3 | 2.6 |
Placebo (PBO) | 67.3 | 17.3 | 8.7 | 3.8 | 1.9 | 1.0 |
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Intensity of Action From Baseline in the MSC Score Over Period III
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | >= 20% | < 50% | >= 50% | < 70% | >= 70% |
---|
Levocetirizine (LCTZ) | 16.7 | 83.3 | 48.1 | 51.9 | 69.9 | 30.1 |
Montelukast (MLKT) | 31.8 | 68.2 | 63.6 | 36.4 | 86.1 | 13.9 |
Placebo (PBO) | 48.1 | 51.9 | 84.6 | 15.4 | 89.4 | 10.6 |
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Intensity of Action From Baseline in the MSC Score Over Period II
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period II [Day 2, from 9:30 am to 11:00 am]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | >= 20% | < 50% | >= 50% | < 70% | >= 70% |
---|
Levocetirizine (LCTZ) | 32.1 | 67.9 | 63.5 | 36.5 | 83.3 | 16.7 |
Montelukast (MLKT) | 53.6 | 46.4 | 87.4 | 12.6 | 95.4 | 4.6 |
Placebo (PBO) | 67.3 | 32.7 | 93.3 | 6.7 | 98.1 | 1.9 |
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Intensity of Action From Baseline in the MSC Score Over Period I
The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline. (NCT00295022)
Timeframe: Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | >= 20% | < 50% | >= 50% | < 70% | >= 70% |
---|
Levocetirizine (LCTZ) | 21.0 | 79.0 | 68.8 | 31.2 | 87.9 | 12.1 |
Montelukast (MLKT) | 32.7 | 67.3 | 67.9 | 32.1 | 92.3 | 7.7 |
Placebo (PBO) | 54.3 | 45.7 | 80.0 | 20.0 | 95.2 | 4.8 |
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Variability of Action From Baseline in the MSC Score Over Period I
"The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:~< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%." (NCT00295022)
Timeframe: Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
,,
Intervention | percentage of participants (Number) |
---|
| < 20% | 20%-35% | 35%-50% | 50%-65% | 65%-80% | >=80% |
---|
Levocetirizine (LCTZ) | 21.0 | 22.9 | 24.8 | 12.7 | 15.3 | 3.2 |
Montelukast (MLKT) | 32.7 | 19.2 | 16.0 | 20.5 | 8.3 | 3.2 |
Placebo (PBO) | 54.3 | 15.2 | 10.5 | 12.4 | 4.8 | 2.9 |
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Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline to Day 2
,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Postnasal Drip Score | Watery Eyes Score | Itchy Eyes/Ears Score | Itchy Throat Score | Cough Score | Sneezes Score | Nose Blows Score | Nasal Congestion Score |
---|
Levocetirizine (LCTZ) | -1.02 | -1.05 | -1.05 | -1.11 | -0.97 | -1.17 | -1.03 | -0.86 | -1.23 | -2.00 | -0.67 |
Montelukast (MLKT) | -0.84 | -0.79 | -0.85 | -0.87 | -0.77 | -0.81 | -0.78 | -0.74 | -0.67 | -1.58 | -0.61 |
Placebo (PBO) | -0.48 | -0.46 | -0.45 | -0.62 | -0.44 | -0.51 | -0.54 | -0.71 | -0.35 | -1.02 | -0.38 |
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Change From Baseline in the Individual Symptom Scores Over Period III
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Postnasal Drip Score | Watery Eyes Score | Itchy Eyes/Ears Score | Itchy Throat Score | Cough Score | Sneezes Score | Nose Blows Score | Nasal Congestion Score |
---|
Levocetirizine (LCTZ) | -1.23 | -1.25 | -1.26 | -1.32 | -1.11 | -1.34 | -1.15 | -0.97 | -1.40 | -2.32 | -0.79 |
Montelukast (MLKT) | -0.93 | -0.89 | -0.96 | -0.97 | -0.84 | -0.87 | -0.86 | -0.84 | -0.78 | -1.82 | -0.67 |
Placebo (PBO) | -0.52 | -0.47 | -0.50 | -0.67 | -0.36 | -0.42 | -0.54 | -0.78 | -0.48 | -1.22 | -0.43 |
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Change From Baseline in the Individual Symptom Scores Over Period II
"Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion Score.~The subjects had to evaluate the severity of the symptoms using a scale from None to Very severe (ranging from 0 to 5).~For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.~The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.~Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline." (NCT00295022)
Timeframe: Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
,,
Intervention | units on a scale (Least Squares Mean) |
---|
| Runny Nose Score | Itchy Nose Score | Sniffles Score | Postnasal Drip Score | Watery Eyes Score | Itchy Eyes/Ears Score | Itchy Throat Score | Cough Score | Sneezes Score | Nose Blows Score | Nasal Congestion Score |
---|
Levocetirizine (LCTZ) | -0.85 | -0.84 | -0.83 | -0.90 | -0.66 | -0.81 | -0.78 | -0.70 | -1.28 | -1.84 | -0.43 |
Montelukast (MLKT) | -0.53 | -0.40 | -0.48 | -0.52 | -0.46 | -0.40 | -0.39 | -0.58 | -0.40 | -0.99 | -0.35 |
Placebo (PBO) | -0.18 | -0.22 | -0.10 | -0.37 | -0.20 | -0.18 | -0.19 | -0.49 | -0.19 | -0.38 | -0.19 |
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Time to First Feeling of Improvement During Period I
During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms). (NCT00295022)
Timeframe: During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Intervention | minutes (Median) |
---|
Placebo (PBO) | 101.02 |
Levocetirizine (LCTZ) | 70.02 |
Montelukast (MLKT) | 63.02 |
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Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
The number of days after treatment discontinuation until a measurable wheal and flare response. (NCT00359138)
Timeframe: Starting at Day 8
Intervention | Days (Mean) |
---|
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule | 5 |
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule | 4 |
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule | NA |
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Global Improvement 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. (NCT00375713)
Timeframe: At endpoint during the 14 day treatment period
,
Intervention | Participants (Number) |
---|
| Marked improvement | Moderate improvement | Mild improvement | No change | Exacerbation |
---|
Cetirizine | 52 | 54 | 47 | 15 | 1 |
Levocetirizine | 47 | 62 | 39 | 18 | 1 |
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Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
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. (NCT00375713)
Timeframe: Day 7 and 14
,
Intervention | Participants (Number) |
---|
| Responder | Non-Responder |
---|
Cetirizine | 134 | 38 |
Levocetirizine | 131 | 37 |
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Change From Baseline in the Mean Pruritus Severity Score 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. (NCT00375713)
Timeframe: Baseline and at endpoint during the 14 day treatment period
Intervention | Units on a scale (Mean) |
---|
Levocetirizine | 1.15 |
Cetirizine | 1.21 |
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Duration of Pruritus (Stated in Categories) 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. (NCT00375713)
Timeframe: At endpoint during the 14 day treatment period
Intervention | Units on a scale (Mean) |
---|
Levocetirizine | 2.13 |
Cetirizine | 2.20 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | beats per minute (Mean) |
---|
Placebo | -1.5 |
Levocetirizine | 1.3 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | micromole per liter [µmol/L] (Median) |
---|
Placebo | 0.000 |
Levocetirizine | 0.000 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
The RR interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 9.2 |
Levocetirizine | -6.9 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | unit per liter [U/L] (Median) |
---|
Placebo | -1.5 |
Levocetirizine | 1.0 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | unit per liter [U/L] (Median) |
---|
Placebo | -1.0 |
Levocetirizine | 1.0 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | micromole per liter [µmol/L] (Median) |
---|
Placebo | -0.8840 |
Levocetirizine | 1.7680 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
(NCT00619801)
Timeframe: Baseline, 14 days
Intervention | millimole per liter [mmol/L] (Median) |
---|
Placebo | -0.1785 |
Levocetirizine | 0.0000 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
The PR interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 0.5 |
Levocetirizine | -0.8 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
The QRS duration refers to the respective time duration in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 0.3 |
Levocetirizine | 0.9 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
The QT interval refers to the respective time interval in the Electrocardiogram (ECG). (NCT00619801)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | -2.8 |
Levocetirizine | -1.5 |
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Mean 24-hour Reflective Total 5 Symptoms Score (T5SS)
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). The total score varies from 0 to 15. (NCT00621959)
Timeframe: Over the total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 8.96 |
LCTZ | 8.77 |
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores. The overall RQLQ score varies from 0 to 6. (NCT00621959)
Timeframe: Baseline and endpoint, defined as the last available post-baseline observation during the two-week treatment period (in days)
Intervention | points on a scale (Mean) |
---|
Placebo | -1.07 |
LCTZ | -1.12 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | beats per minute (Mean) |
---|
Placebo | -7.6 |
Levocetirizine | -4.0 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | unit per liter [U/L] (Median) |
---|
Placebo | -2.0 |
Levocetirizine | -1.0 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (AST)
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | unit per liter [U/L] (Median) |
---|
Placebo | 2.0 |
Levocetirizine | -1.0 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | micromole per liter [μmol/L] (Median) |
---|
Placebo | -0.8840 |
Levocetirizine | -0.8840 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | millimole per liter [mmol/L] (Median) |
---|
Placebo | 0.0000 |
Levocetirizine | 0.0000 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
The PR interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 0.8 |
Levocetirizine | 3.1 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
The QRS duration refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 1.4 |
Levocetirizine | 0.3 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
The QT interval refers to the respective time in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 4.5 |
Levocetirizine | -0.3 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
The RR interval refers to the respective time interval in the Electrocardiogram (ECG) (NCT00628108)
Timeframe: Baseline, 14 days
Intervention | milliseconds (Mean) |
---|
Placebo | 28.0 |
Levocetirizine | 14.9 |
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Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
(NCT00628108)
Timeframe: Baseline, 14 days
Intervention | micromole per liter [µmol/L] (Median) |
---|
Placebo | 0.000 |
Levocetirizine | 0.000 |
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Total Nasal Symptom Score (TNSS) Over the Second Week
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 8.23 |
Levocetirizine | 7.45 |
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Total Nasal Symptom Score (TNSS) Over the Total Treatment Period (14 Days)
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 8.73 |
Levocetirizine | 7.94 |
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Total Ocular Symptom Score (TOSS) Over the First Week
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 4.29 |
Levocetirizine | 3.99 |
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Total Ocular Symptom Score (TOSS) Over the Second Week
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 3.89 |
Levocetirizine | 3.60 |
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Total Ocular Symptom Score (TOSS) Over the Total Treatment Period (14 Days)
Total Ocular Symptoms Score (TOSS) is the sum of ocular itching/burning, ocular tearing/watering and ocular redness scores. Each individual symptom was scored from 0 (none) to 3 (severe). TOSS ranges from 0 to 9. An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 4.13 |
Levocetirizine | 3.82 |
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Global Patient's Rating of Efficacy at Endpoint of the Two Week Treatment Period
"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Patient had to tick a box going from Marked worsening to Marked improvement." (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
,
Intervention | participants (Number) |
---|
| Marked Worsening | Moderate Worsening | Slight Worsening | No Change | Slight Improvement | Moderate Improvement | Marked Improvement |
---|
Levocetirizine | 6 | 11 | 8 | 69 | 95 | 62 | 33 |
Placebo | 14 | 16 | 21 | 86 | 81 | 52 | 22 |
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Global Physician's Rating of Efficacy at Endpoint During the Two Week Treatment Period
"Endpoint is defined as the last available postbaseline measurement during the two week treatment period.Physician had to tick a box going from Marked worsening to Marked improvement." (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
,
Intervention | participants (Number) |
---|
| Marked Worsening | Moderate Worsening | Slight Worsening | No Change | Slight Improvement | Moderate Improvement | Marked Improvement |
---|
Levocetirizine | 5 | 7 | 7 | 70 | 92 | 65 | 38 |
Placebo | 5 | 13 | 18 | 106 | 75 | 50 | 25 |
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Sleepiness According to Epworth Sleepiness Scale (ESS) Score at Baseline and at Endpoint During the Two-week Treatment Period
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
,
Intervention | participants (Number) |
---|
| ESS score < 8 at Baseline and < 8 at Endpoint | ESS score < 8 at Baseline and ≥ 8 at Endpoint | ESS score ≥ 8 at Baseline and < 8 at Endpoint | ESS score ≥ 8 at Baseline and ≥ 8 at Endpoint |
---|
Levocetirizine | 63 | 13 | 57 | 151 |
Placebo | 66 | 16 | 46 | 165 |
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Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -1.01 |
Levocetirizine | -2.68 |
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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Endpoint During the Two-week Treatment Period
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -1.02 |
Levocetirizine | -1.79 |
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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 1
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.67 |
Levocetirizine | -0.91 |
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Change From Baseline in Epworth Sleepiness Scale (ESS) Score at Week 2
The Epworth Sleepiness Scale (ESS) is the criterion standard for measuring daytime sleepiness in adults. Subjects are asked to rate the chances of dozing off or falling asleep in eight situations encountered in daily life on a scale of 0 to 3, with scores ranging from 0 to 24. A score >= 8 indicates sleepiness. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -1.05 |
Levocetirizine | -1.78 |
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -0.93 |
Levocetirizine | -1.31 |
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.60 |
Levocetirizine | -0.94 |
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Change From Baseline in Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Overall health-related quality of life is expressed as the mean of the seven dimension scores and ranges from 0 to 6. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -0.95 |
Levocetirizine | -1.34 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -1.28 |
Levocetirizine | -1.55 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.80 |
Levocetirizine | -1.13 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Activities Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -1.30 |
Levocetirizine | -1.58 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -0.80 |
Levocetirizine | -1.21 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.51 |
Levocetirizine | -0.91 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Emotional Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -0.82 |
Levocetirizine | -1.24 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -0.88 |
Levocetirizine | -1.36 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.62 |
Levocetirizine | -1.04 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Eye Symptoms Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -0.89 |
Levocetirizine | -1.40 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -1.05 |
Levocetirizine | -1.45 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.68 |
Levocetirizine | -1.05 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Nasal Symptoms Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -1.08 |
Levocetirizine | -1.49 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -0.71 |
Levocetirizine | -1.05 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.42 |
Levocetirizine | -0.70 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Non-nose/Eye Symptoms Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -0.73 |
Levocetirizine | -1.08 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -1.22 |
Levocetirizine | -1.62 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.76 |
Levocetirizine | -1.14 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Practical Problems Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -1.24 |
Levocetirizine | -1.66 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Endpoint During the Two-week Treatment Period
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | points on a scale (Mean) |
---|
Placebo | -0.90 |
Levocetirizine | -1.19 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 1
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | points on a scale (Mean) |
---|
Placebo | -0.59 |
Levocetirizine | -0.84 |
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Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Sleep Score at Week 2
The RQLQ is a validated instrument composed of 28 questions covering 7 dimensions of health. Each question is scored on a scale of 0 to 6 (in which 0 = not troubled and 6 = extremely troubled), and the mean value for each health dimension is calculated. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | points on a scale (Mean) |
---|
Placebo | -0.93 |
Levocetirizine | -1.20 |
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Ocular Pruritus Score Over the Total Treatment Period (14 Days)
The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.59 |
Levocetirizine | 1.51 |
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Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -1.33 |
Levocetirizine | -2.48 |
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Change From Baseline in the Dimension 1 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Work Time Missed Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -0.93 |
Levocetirizine | -2.83 |
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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -8.06 |
Levocetirizine | -13.98 |
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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -5.64 |
Levocetirizine | -11.23 |
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Change From Baseline in the Dimension 2 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment While Working Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -8.59 |
Levocetirizine | -14.34 |
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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -8.61 |
Levocetirizine | -14.49 |
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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -5.80 |
Levocetirizine | -11.77 |
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Change From Baseline in the Dimension 3 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Work Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -9.14 |
Levocetirizine | -14.89 |
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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | 0.25 |
Levocetirizine | -3.64 |
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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -2.82 |
Levocetirizine | -3.27 |
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Change From Baseline in the Dimension 4 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Class Time Missed Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -0.03 |
Levocetirizine | -3.64 |
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Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -6.33 |
Levocetirizine | -7.73 |
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Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -2.86 |
Levocetirizine | -6.00 |
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Change From Baseline in the Dimension 5 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Impairment in the Classroom Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -6.55 |
Levocetirizine | -7.73 |
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Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -5.22 |
Levocetirizine | -8.65 |
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Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -3.05 |
Levocetirizine | -7.18 |
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Change From Baseline in the Dimension 6 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Overall Classroom Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -5.52 |
Levocetirizine | -8.65 |
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Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Endpoint During the Two-week Treatment Period
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. Endpoint is defined as the last available postbaseline measurement during the two week treatment period. (NCT00653224)
Timeframe: Baseline and at endpoint of the 2 week treatment period
Intervention | percent change (Mean) |
---|
Placebo | -11.71 |
Levocetirizine | -18.46 |
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Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 1
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 1
Intervention | percent change (Mean) |
---|
Placebo | -6.85 |
Levocetirizine | -14.29 |
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Change From Baseline in the Dimension 7 Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) Score: Percentage of Activity Impairment Due to Allergy at Week 2
The Work Productivity and Activity Impairment-Allergy Specific (WPAI-AS) has been validated to measure generic and allergy-specific performance impairment of work and classroom productivity and of regular daily activity. Higher scores (0% to 100%) indicate greater impairment and a negative change from baseline indicates improvement. (NCT00653224)
Timeframe: Baseline and week 2
Intervention | percent change (Mean) |
---|
Placebo | -12.05 |
Levocetirizine | -18.84 |
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Mean 24-hour Reflective Total 5 Symptoms Score (T5SS) Over the Total Treatment Period (14 Days)
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). Total score ranges from 0 to 15. (NCT00653224)
Timeframe: Over the total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 8.68 |
Levocetirizine | 7.87 |
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Nasal Congestion Score Over the First Week
The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.98 |
Levocetirizine | 1.92 |
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Nasal Congestion Score Over the Second Week
The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.81 |
Levocetirizine | 1.67 |
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Nasal Congestion Score Over the Total Treatment Period (14 Days)
The nasal congestion score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.91 |
Levocetirizine | 1.80 |
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Nasal Pruritus Score Over the First Week
The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.80 |
Levocetirizine | 1.61 |
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Nasal Pruritus Score Over the Second Week
The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.63 |
Levocetirizine | 1.45 |
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Nasal Pruritus Score Over the Total Treatment Period (14 Days)
The nasal pruritus score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.73 |
Levocetirizine | 1.54 |
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Ocular Itching/Burning Score Over the First Week
The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.58 |
Levocetirizine | 1.53 |
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Ocular Itching/Burning Score Over the Second Week
The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.42 |
Levocetirizine | 1.39 |
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Ocular Itching/Burning Score Over the Total Treatment Period (14 Days)
The ocular itching/burning score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.52 |
Levocetirizine | 1.47 |
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Ocular Pruritus Score Over the First Week
The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.65 |
Levocetirizine | 1.56 |
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Ocular Pruritus Score Over the Second Week
The ocular pruritus score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.52 |
Levocetirizine | 1.44 |
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Ocular Redness Score Over the First Week
The ocular redness score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.31 |
Levocetirizine | 1.21 |
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Ocular Redness Score Over the Second Week
The ocular redness score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.20 |
Levocetirizine | 1.05 |
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Ocular Redness Score Over the Total Treatment Period (14 Days)
The ocular redness score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.27 |
Levocetirizine | 1.14 |
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Ocular Tearing/Watering Score Over the First Week
The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.40 |
Levocetirizine | 1.26 |
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Ocular Tearing/Watering Score Over the Second Week
The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.27 |
Levocetirizine | 1.16 |
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Ocular Tearing/Watering Score Over the Total Treatment Period (14 Days)
The ocular tearing/watering score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.34 |
Levocetirizine | 1.22 |
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Post-nasal Drip Score Over the First Week
The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.72 |
Levocetirizine | 1.65 |
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Post-nasal Drip Score Over the Second Week
The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.55 |
Levocetirizine | 1.48 |
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Post-nasal Drip Score Over the Total Treatment Period (14 Days)
The post-nasal drip score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.64 |
Levocetirizine | 1.57 |
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Rhinorrhea Score Over the First Week
The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.81 |
Levocetirizine | 1.59 |
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Rhinorrhea Score Over the Second Week
The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.63 |
Levocetirizine | 1.44 |
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Rhinorrhea Score Over the Total Treatment Period (14 Days)
The rhinorrhea score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.73 |
Levocetirizine | 1.53 |
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Sneezing Score Over the First Week
The sneezing score ranges from 0 (none) to 3 (severe). An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 1.80 |
Levocetirizine | 1.57 |
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Sneezing Score Over the Second Week
The sneezing score ranges from 0 (none) to 3 (severe). An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 1.62 |
Levocetirizine | 1.41 |
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Sneezing Score Over the Total Treatment Period (14 Days)
The sneezing score ranges from 0 (none) to 3 (severe). An average over the total treatment period is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 1.72 |
Levocetirizine | 1.50 |
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Total 4 Symptoms Score (T4SS) Over the First Week
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 7.07 |
Levocetirizine | 6.32 |
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Total 4 Symptoms Score (T4SS) Over the Second Week
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 6.39 |
Levocetirizine | 5.74 |
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Total 4 Symptoms Score (T4SS) Over the Total Treatment Period (14 Days)
Total 4 Symptoms Score (T4SS) is the sum of rhinorrhea, sneezing, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T4SS ranges from 0 to 12. An average over the total treatment period of 14 days is provided. (NCT00653224)
Timeframe: Over total treatment period (14 days)
Intervention | points on a scale (Mean) |
---|
Placebo | 6.78 |
Levocetirizine | 6.07 |
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Total 5 Symptoms Score (T5SS) Over the First Week
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the first week is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 9.04 |
Levocetirizine | 8.24 |
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Total 5 Symptoms Score (T5SS) Over the Second Week
Total 5 Symptoms Score (T5SS) is the sum of rhinorrhea, sneezing, nasal congestion, itchy nose and itchy eyes scores. Each individual symptom was scored from 0 (none) to 3 (severe). T5SS ranges from 0 to 15. An average over the second week of treatment is provided. (NCT00653224)
Timeframe: Over week 2
Intervention | points on a scale (Mean) |
---|
Placebo | 8.20 |
Levocetirizine | 7.41 |
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Total Nasal Symptom Score (TNSS) Over the First Week
Total Nasal Symptoms Score (TNSS) is the sum of sneezing, rhinorrhea, nasal itching, nasal congestion and post-nasal drip scores. Each individual symptom was scored from 0 (none) to 3 (severe). TNSS ranges from 0 to 15. An average over the first week of treatment is provided. (NCT00653224)
Timeframe: Over week 1
Intervention | points on a scale (Mean) |
---|
Placebo | 9.11 |
Levocetirizine | 8.34 |
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Modified Epworth Sleepiness Scale
"Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36.~This was mean data for all interventions." (NCT00826943)
Timeframe: 36 days of the study
Intervention | units on a scale (Mean) |
---|
Placebo | 6.14 |
Levocetirizine | 6.69 |
Cetirizine | 7.48 |
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Likert Score Rating Global Sedation
"Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study.~This was mean data for all interventions." (NCT00826943)
Timeframe: duration of study (36 days)
Intervention | Likert score (Mean) |
---|
Placebo | 2.80 |
Levocetirizine | 3.07 |
Cetirizine | 3.54 |
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Total Four Symptom Scores (Allergy Symptoms)
"Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated.~This was mean data for all interventions." (NCT00826943)
Timeframe: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)
Intervention | TFSS scores (Mean) |
---|
Placebo | 4.41 |
Levocetirizine | 3.14 |
Cetirizine | 2.67 |
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Dermatology Life Quality Index (DLQI) Questionnaire Scores at Baseline, Week 2 and Week 4
Consented subjects who met inclusion/exclusion criteria were asked to complete a DLQI (Dermatology Life Quality Index)at Baseline, Week 2 and Week 4. The DLQI is a 10 item questionnaire broken down into 6 domains; symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment with a total score ranging from 0-30 (no effect on subject's life for 0, extremely large effect on subject's life for 30) (NCT00884325)
Timeframe: Baseline - Week 2 - Week 4
,
Intervention | units on a scale (Median) |
---|
| DLQI - Baseline | DLQI - Week 2 | DLQI - Week 4 |
---|
Subjects Receiving Placebo | 8.00 | 5.5 | 4.00 |
Subjects Receiving Xyzal | 7.5 | 3.5 | 2.00 |
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Pruritus VAS Scores at Baseline, Week 2 and Week 4
Consented subjects who met inclusion/exclusion criteria were assigned either 5mg levocetirizine dihydrochloride (Xyzal) or placebo to be taken daily each evening for 28 days. Subjects were asked to complete a Visual Analog Scale to measure itch at Baseline, Week 2 and Week 4. The scale is an eleven point scale ranging from 0-10 with 0 indicating no itch to 10 indicating itch that frequently interferes with daily activities. (NCT00884325)
Timeframe: Baseline - Week 2-Week 4
,
Intervention | units on a scale (Median) |
---|
| Baseline | Week 2 | Week 4 |
---|
Subjects Receiving Placebo | 7.5 | 5.9 | 6.4 |
Subjects Receiving Xyzal | 7.8 | 6.10 | 4.15 |
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Characterize Contribution of Histamine in Children With Asthma
The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma. (NCT01392859)
Timeframe: one year
Intervention | flux units on a continuous scale (Mean) |
---|
| Hyper-Reactive- | Normo-Reactive | Hypo-Reactive |
---|
Overall Study | 11253.24 | 6464.20 | 3539.67 |
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Cmax and Cmin of Levocetirizine in Plasma
Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa. (NCT01563081)
Timeframe: Weeks 1 and 2/Early Withdrawal
,
Intervention | nanograms per milliliter (Median) |
---|
| Cmax | Cmin |
---|
Levocetirizine: >=12 Months and <24 Months Old | 213.440 | 48.330 |
Levocetirizine: >=6 Months and <12 Months Old | 206.780 | 17.710 |
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Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
The investigator comprehensively assessed the pariticipant's severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none. (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal
Intervention | participants (Number) |
---|
| FDOT, none | FDOT, slight | FDOT, mild | FDOT, moderate | FDOT, severe | Week 1, none | Week 1, slight | Week 1, mild | Week 1, moderate | Week 1, severe | Week 2/EW, none | Week 2/EW, slight | Week 2/EW, mild | Week 2/EW, moderate | Week 2/EW, severe |
---|
Levocetrizine: Total Population | 0 | 7 | 17 | 11 | 5 | 6 | 14 | 11 | 7 | 2 | 13 | 8 | 11 | 8 | 0 |
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Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)
A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record. (NCT01563081)
Timeframe: up to Week 2/Early Withdrawal (EW)
,,
Intervention | participants (Number) |
---|
| Any Adverse Event | Any Serious Adverse Event |
---|
Levocetirizine: >=12 Months and <24 Months Old | 17 | 0 |
Levocetirizine: >=6 Months and <12 Months Old | 15 | 0 |
Levocetirizine: Total Population | 32 | 0 |
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Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression
"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline." (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal
Intervention | participants (Number) |
---|
| AR, Week 1, significantly improved, n=20 | AR, Week 2/EW, significantly improved, n=20 | AR, Week 1, moderately improved, n=20 | AR, Week 2/EW, moderately improved, n=20 | AR, Week 1, mildly improved, n=20 | AR, Week 2/EW, mildly improved, n=20 | AR, Week 1, no change, n=20 | AR, Week 2/EW, no change, n=20 | AR, Week 1, mildly worse, n=20 | AR, Week 2/EW, mildly worse, n=20 | AR, Week 1, moderately worse, n=20 | AR, Week 2/EW, moderately worse, n=20 | AR, Week 1, significantly worse, n=20 | AR, Week 2/EW, significantly worse, n=20 | PAWSD, Week 1, significantly improved, n=40 | PAWSD, Week 2/EW, significantly improved, n=40 | PAWSD, Week 1, moderately improved, n=40 | PAWSD, Week 2/EW, moderately improved, n=40 | PAWSD, Week 1, mildly improved, n=40 | PAWSD, Week 2/EW, mildly improved, n=40 | PAWSD, Week 1, no change, n=40 | PAWSD, Week 2/EW, no change, n=40 | PAWSD, Week 1, mildly worse, n=40 | PAWSD, Week 2/EW, mildly worse, n=40 | PAWSD, Week 1, moderately worse, n=40 | PAWSD, Week 2/EW, moderately worse, n=40 | PAWSD, Week 1, significantly worse, n=40 | PAWSD, Week 2/EW, significantly worse, n=40 |
---|
Levocetirizine: Total Population | 4 | 8 | 5 | 5 | 4 | 5 | 7 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 6 | 11 | 16 | 13 | 14 | 12 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
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Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator
The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened. (NCT01563081)
Timeframe: First day of treatment; Weeks 1 and 2/Early Withdrawal
Intervention | participants (Number) |
---|
| AR, Week 1, markedly improved, n=20 | AR, Week 2/EW, markedly improved, n=20 | AR, Week moderately improved, n=20 | AR, Week 2/EW, moderately improved, n=20 | AR, Week 1, slightly improved, n=20 | AR, Week 2/EW, slightly improved, n=20 | AR, Week 1, no change, n=20 | AR, Week 2/EW, no change, n=20 | AR, Week 1, worsened, n=20 | AR, Week 2/EW, worsened, n=20 | PAWSD, Week 1, markedly improved, n=40 | PAWSD, Week 2/EW, markedly improved, n=40 | PAWSD, Week 1, moderately improved, n=40 | PAWSD, Week 2/EW, moderately improved, n=40 | PAWSD, Week 1, slightly improved, n=40 | PAWSD, Week 2/EW, slightly improved, n=40 | PAWSD, Week 1, no change, n=40 | PAWSD, Week 2/EW, no change, n=40 | PAWSD, Week 1, worsened, n=40 | PAWSD, Week 2/EW, worsened, n=40 |
---|
Levocetrizine: Total Population | 7 | 12 | 4 | 3 | 3 | 4 | 6 | 1 | 0 | 0 | 6 | 10 | 15 | 19 | 12 | 8 | 7 | 3 | 0 | 0 |
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Flaire Diameter (mm)
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this. (NCT01586091)
Timeframe: 24 hours per treatment
Intervention | mm (Mean) |
---|
Placebo | 69.4 |
Levocetirizin | 20.4 |
Fexofenadine | 39.9 |
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Pruritus as Assessed by the VAS Score
"We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a 0 and 100 at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point." (NCT01586091)
Timeframe: up to 10 minutes after skin prick test performed 24 hours after drug administration
Intervention | mm (Mean) |
---|
Levocetirizin | 11.5 |
Fexofenadine | 25.4 |
Placebo | 46.0 |
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Wheal Volume (cm3)
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany). (NCT01586091)
Timeframe: 24 hours per treatment
Intervention | cm3 (Mean) |
---|
Placebo | 174.6 |
Levocetirizin | 35.2 |
Fexofenadine | 106.3 |
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Progression Free Survival (Arm A)
"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT01722162)
Timeframe: Until progressive disease (PD) (estimated to be 92 days)
Intervention | proportion of patients with PFS (Number) |
---|
| PFS Days = 29 | PFS Days = 36 | PFS Days = 43 | PFS Days = 46 | PFS Days = 50 | PFS Days = 92 |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 0.946 | 0.892 | 0.739 | 0.685 | 0.630 | 0.575 |
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Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (NCT01722162)
Timeframe: Up to 6 months
,
Intervention | participants (Number) |
---|
| Small intestinal obstruction | Fatigue | Urinary tract infection | Blood bilirubin increased | Peripheral motor neuropathy | Peripheral sensory neuropathy | Dyspnea | Hypertension | Thromboembolic event | Anemia | Heart failure | Colonic fistula | Colonic perforation | Gram-negative bacilli infection | Clostridium bloodstream infection | Alanine aminotransferase increased | Anorexia | Bone pain | Generalized muscle weakness | Muscle weakness lower limbs | Urinary retention | Respiratory failure |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 1 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine) | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
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Progression Free Survival (Arm B)
"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase." (NCT01722162)
Timeframe: Until progressive disease (PD) (up to 60 days)
Intervention | proportion of patients with PFS (Number) |
---|
| PFS Days = 29 | PFS Days = 33 | PFS Days = 44 | PFS Days = 50 | PFS Days = 54 | PFS Days = 60 |
---|
Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine) | 0.946 | 0.892 | 0.838 | 0.686 | 0.631 | 0.576 |
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Part 2: Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. (NCT03555890)
Timeframe: Up to 18 days
,
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Part 2: Levocetirizine IRT 5 mg | 0 | 0 |
Part 2: Levocetirizine ODT 5 mg | 6 | 0 |
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Part 2: Change From Baseline in SBP and DBP
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | mmHg (Mean) |
---|
| SBP, 1 hour | SBP, 24 hour | SBP, 48 hour | DBP, 1 hour | DBP, 24 hour | DBP, 48 hour |
---|
Part 2: Levocetirizine IRT 5 mg | -0.9 | -1.2 | 0.3 | -2.6 | -1.2 | -0.2 |
Part 2: Levocetirizine ODT 5 mg | 0.2 | -1.9 | 0.7 | -2.6 | -2.3 | -0.6 |
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Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
,
Intervention | Millisecond (Mean) |
---|
| PR interval, 1 hour | PR interval, 48 hour | QRS duration, 1 hour | QRS duration, 48 hour | QT interval, 1 hour | QT interval, 48 hour | QTcF interval, 1 hour | QTcF interval, 48 hour |
---|
Part 2: Levocetirizine IRT 5 mg | -2.8 | 0.6 | -1.9 | -0.4 | 3.1 | -11.4 | -0.9 | -7.6 |
Part 2: Levocetirizine ODT 5 mg | -3.2 | 1.2 | -1.4 | 0.3 | 3.8 | -12.1 | 1.4 | -8.5 |
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Part 2: Change From Baseline in Platelet Count and White Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | GI/L (Mean) |
---|
| Platelet count | White blood cell count |
---|
Part 2: Levocetirizine IRT 5 mg | -2.9 | -1.06 |
Part 2: Levocetirizine ODT 5 mg | -2.5 | -1.14 |
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Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | G/L (Mean) |
---|
| Hemoglobin | Mean corpuscle hemoglobin concentration |
---|
Part 2: Levocetirizine IRT 5 mg | 0.9 | 0.5 |
Part 2: Levocetirizine ODT 5 mg | 0.9 | 0.2 |
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Part 2: Change From Baseline in Heart Rate (ECG)
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
,
Intervention | Beats per minute (Mean) |
---|
| 1 hour | 48 hour |
---|
Part 2: Levocetirizine IRT 5 mg | -1.7 | 1.9 |
Part 2: Levocetirizine ODT 5 mg | -1.0 | 1.7 |
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Part 2: Change From Baseline in Heart Rate
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | Beats per minute (Mean) |
---|
| 1 hour | 24 hour | 48 hour |
---|
Part 2: Levocetirizine IRT 5 mg | -0.6 | 0.6 | 3.0 |
Part 2: Levocetirizine ODT 5 mg | -1.5 | -1.9 | 1.5 |
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Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | UMOL/L (Mean) |
---|
| Direct bilirubin | Total bilirubin | Creatinine | Uric acid |
---|
Part 2: Levocetirizine IRT 5 mg | 0.036 | -0.619 | -3.8746 | 13.6677 |
Part 2: Levocetirizine ODT 5 mg | -0.071 | -0.748 | -3.5913 | 14.0026 |
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Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | MMOL/L (Mean) |
---|
| Calcium | Cholesterol | Chloride | Glucose | High density lipids cholesterol | Potassium | Low density lipids cholesterol | Sodium | Phosphorus inorganic | Triglycerides | Urea/BUN |
---|
Part 2: Levocetirizine IRT 5 mg | 0.015926 | 0.064925 | -0.5 | 0.059053 | -0.047869 | 0.08 | 0.084733 | -0.6 | -0.239770 | 0.03606 | -0.45802 |
Part 2: Levocetirizine ODT 5 mg | 0.015594 | 0.083506 | -0.6 | -0.049728 | -0.049565 | -0.03 | 0.123374 | -1.1 | -0.203831 | -0.02707 | -0.12272 |
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Part 2: Change From Baseline in Body Temperature
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | Degree Celsius (Mean) |
---|
| 1 hour | 24 hour | 48 hour |
---|
Part 2: Levocetirizine IRT 5 mg | 0.09 | 0.08 | 0.03 |
Part 2: Levocetirizine ODT 5 mg | 0.19 | 0.13 | 0.03 |
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Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Percentage (Mean) |
---|
| Basophils | Eosinophils | Lymphocytes | Monocytes | Total neutrophils levels |
---|
Part 2: Levocetirizine IRT 5 mg | 0.04 | -0.74 | -8.07 | -0.48 | 9.25 |
Part 2: Levocetirizine ODT 5 mg | 0.08 | -0.92 | -8.45 | -0.49 | 9.78 |
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Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | IU/L (Mean) |
---|
| Alkaline phosphatase | Alanine amino transferase | Aspartate amino transferase | Creatine kinase | Gamma glutamyl transferase | Lactate dehydrogenase |
---|
Part 2: Levocetirizine IRT 5 mg | -2.3 | -0.7 | -0.1 | -16.3 | -0.1 | -3.7 |
Part 2: Levocetirizine ODT 5 mg | -1.1 | -0.5 | 0.1 | -12.4 | -0.1 | -3.5 |
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Part 2: Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | g/L (Mean) |
---|
| Albumin | Total protein |
---|
Part 2: Levocetirizine IRT 5 mg | 1.4 | 1.9 |
Part 2: Levocetirizine ODT 5 mg | 1.2 | 1.8 |
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Part 1: Urine Specific Gravity
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | Ratio (Mean) |
---|
| Pre-dose | 48 hours |
---|
Part 1: Levocetirizine IRT 5 mg | 1.0144 | 1.0163 |
Part 1: Levocetirizine ODT 5 mg | 1.0158 | 1.0178 |
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Part 1: Urine Potential of Hydrogen (pH)
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | pH (Mean) |
---|
| Pre-dose | 48 hours |
---|
Part 1: Levocetirizine IRT 5 mg | 6.06 | 6.02 |
Part 1: Levocetirizine ODT 5 mg | 6.04 | 6.10 |
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Part 1: Number of Participants With Urinalysis Results by Dipstick Method
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | Participants (Count of Participants) |
---|
| Bilirubin, Pre-dose, negative | Bilirubin, 48 hours, negative | Occult blood, Pre-dose, negative | Occult blood, Pre-dose, trace | Occult blood, 48 hours, negative | Occult blood, 48 hours, trace | Glucose, Pre-dose, negative | Glucose, 48 hours, negative | Ketones, Pre-dose, negative | Ketones, Pre-dose, positive (1+) | Ketones, 48 hours, negative | Protein, Pre-dose, negative | Protein, 48 hours, negative | Urobilinogen, Pre-dose, trace | Urobilinogen, 48 hours, trace |
---|
Part 1: Levocetirizine IRT 5 mg | 24 | 24 | 24 | 0 | 24 | 0 | 24 | 24 | 23 | 1 | 24 | 24 | 24 | 24 | 24 |
Part 1: Levocetirizine ODT 5 mg | 24 | 24 | 23 | 1 | 23 | 1 | 24 | 24 | 24 | 0 | 24 | 24 | 24 | 24 | 24 |
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Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. (NCT03555890)
Timeframe: Up to 18 days
,
Intervention | Participants (Count of Participants) |
---|
| AEs | SAEs |
---|
Part 1: Levocetirizine IRT 5 mg | 0 | 0 |
Part 1: Levocetirizine ODT 5 mg | 0 | 0 |
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Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | Millimeters of mercury (mmHg) (Mean) |
---|
| SBP, 1 hour | SBP, 24 hour | SBP, 48 hour | DBP, 1 hour | DBP, 24 hour | DBP, 48 hour |
---|
Part 1: Levocetirizine IRT 5 mg | 0.4 | 0.6 | 1.3 | -2.2 | 0.0 | 1.1 |
Part 1: Levocetirizine ODT 5 mg | -2.0 | 0.0 | -1.2 | -1.8 | 0.3 | 0.6 |
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Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
,
Intervention | Millisecond (Mean) |
---|
| PR interval, 1 hour | PR interval, 48 hour | QRS duration, 1 hour | QRS duration, 48 hour | QT interval, 1 hour | QT interval, 48 hour | QTcF interval, 1 hour | QTcF interval, 48 hour |
---|
Part 1: Levocetirizine IRT 5 mg | -6.3 | -1.9 | -0.8 | -0.6 | -6.4 | -10.7 | -4.3 | -4.8 |
Part 1: Levocetirizine ODT 5 mg | -7.3 | -5.5 | -0.5 | 1.7 | -9.3 | -14.3 | -6.1 | -9.3 |
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Part 1: Change From Baseline in Platelet Count and White Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Giga per liter (GI/L) (Mean) |
---|
| Platelet count | White blood cell count |
---|
Part 1: Levocetirizine IRT 5 mg | -11.4 | -1.26 |
Part 1: Levocetirizine ODT 5 mg | -6.4 | -0.94 |
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Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Grams per liter (G/L) (Mean) |
---|
| Hemoglobin | Mean corpuscle hemoglobin concentration |
---|
Part 1: Levocetirizine IRT 5 mg | 2.3 | 1.8 |
Part 1: Levocetirizine ODT 5 mg | 2.2 | 2.3 |
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Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])
Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose
,
Intervention | Beats per minute (Mean) |
---|
| 1 hour | 48 hour |
---|
Part 1: Levocetirizine IRT 5 mg | 1.0 | 2.5 |
Part 1: Levocetirizine ODT 5 mg | 1.6 | 2.1 |
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Part 1: Change From Baseline in Heart Rate
Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | Beats per minute (Mean) |
---|
| 1 hour | 24 hour | 48 hour |
---|
Part 1: Levocetirizine IRT 5 mg | -0.9 | -0.1 | 2.5 |
Part 1: Levocetirizine ODT 5 mg | -2.3 | -0.8 | 0.8 |
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Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 8.784 |
Part 1: Levocetirizine IRT 5 mg | 8.544 |
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Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Millimoles per liter (MMOL/L) (Mean) |
---|
| Calcium | Cholesterol | Chloride | Glucose | High density lipids cholesterol | Potassium | Low density lipids cholesterol | Sodium | Phosphorus inorganic | Triglycerides | Urea/BUN |
---|
Part 1: Levocetirizine IRT 5 mg | 0.018713 | 0.054953 | -1.0 | -0.050884 | -0.063573 | 0.10 | 0.038790 | -0.7 | -0.182977 | -0.00047 | 0.08033 |
Part 1: Levocetirizine ODT 5 mg | 0.032227 | 0.117448 | -0.9 | -0.067075 | -0.032325 | 0.13 | 0.059263 | -0.6 | -0.193740 | 0.04520 | 0.01934 |
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Part 1: Change From Baseline in Body Temperature
Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose
,
Intervention | Degree Celsius (Mean) |
---|
| 1 hour | 24 hour | 48 hour |
---|
Part 1: Levocetirizine IRT 5 mg | 0.02 | 0.09 | 0.01 |
Part 1: Levocetirizine ODT 5 mg | 0.20 | -0.01 | 0.06 |
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Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Percentage (Mean) |
---|
| Basophils | Eosinophils | Lymphocytes | Monocytes | Total neutrophils levels |
---|
Part 1: Levocetirizine IRT 5 mg | 0.01 | -0.52 | -5.96 | 0.16 | 6.32 |
Part 1: Levocetirizine ODT 5 mg | -0.01 | -0.53 | -5.94 | -0.16 | 6.64 |
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Part 1: Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Grams per liter (g/L) (Mean) |
---|
| Albumin | Total protein |
---|
Part 1: Levocetirizine IRT 5 mg | 1.5 | 2.3 |
Part 1: Levocetirizine ODT 5 mg | 1.6 | 2.7 |
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Part 2: Vz/F of Levocetirizine
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Liters (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 34.82 |
Part 2: Levocetirizine IRT 5 mg | 33.91 |
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Part 2: Tmax of Levocetirizine
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Median) |
---|
Part 2: Levocetirizine ODT 5 mg | 1.0000 |
Part 2: Levocetirizine IRT 5 mg | 1.0000 |
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Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Liters per hour (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 2.758 |
Part 1: Levocetirizine IRT 5 mg | 2.699 |
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Part 2: t1/2 of Levocetirizine
Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 9.024 |
Part 2: Levocetirizine IRT 5 mg | 8.933 |
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Part 2: MRT of Levocetirizine
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 12.573 |
Part 2: Levocetirizine IRT 5 mg | 12.272 |
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Part 2: Kel (lambda_z) of Levocetirizine
Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Per hour (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 0.07681 |
Part 2: Levocetirizine IRT 5 mg | 0.07760 |
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Part 2: Cmax of Levocetirizine
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 191.5 |
Part 2: Levocetirizine IRT 5 mg | 223.6 |
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Part 2: CL/F of Levocetirizine
Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Liters per hour (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 2.675 |
Part 2: Levocetirizine IRT 5 mg | 2.631 |
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Part 2: Change From Baseline in Reticulocytes
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Percentage of reticulocytes (Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | -0.0001 |
Part 2: Levocetirizine IRT 5 mg | -0.0004 |
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Part 2: Change From Baseline in Red Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Trillion cells per liter (Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 0.040 |
Part 2: Levocetirizine IRT 5 mg | 0.041 |
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Part 2: Change From Baseline in Mean Corpuscle Volume
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Femtoliters (Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | -0.2 |
Part 2: Levocetirizine IRT 5 mg | -0.3 |
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Part 2: Change From Baseline in Mean Corpuscle Hemoglobin
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Picograms (Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | -0.07 |
Part 2: Levocetirizine IRT 5 mg | -0.07 |
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Part 2: Change From Baseline in Amylase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | U/L (Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 7.4 |
Part 2: Levocetirizine IRT 5 mg | 7.1 |
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Part 2: AUC(0-t) of Levocetirizine
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Intervention | Hr*ng/mL (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 1809.9 |
Part 2: Levocetirizine IRT 5 mg | 1843.5 |
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Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine
Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Liters (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 34.95 |
Part 1: Levocetirizine IRT 5 mg | 33.27 |
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Part 2: %AUCex of Levocetirizine
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Percentage AUCex (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 2.973 |
Part 2: Levocetirizine IRT 5 mg | 2.779 |
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Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine
Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Median) |
---|
Part 1: Levocetirizine ODT 5 mg | 0.5000 |
Part 1: Levocetirizine IRT 5 mg | 0.7500 |
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Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine
Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Percentage AUCex (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 2.772 |
Part 1: Levocetirizine IRT 5 mg | 2.500 |
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Part 1: Mean Residence Time (MRT) of Levocetirizine
Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hours (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 11.545 |
Part 1: Levocetirizine IRT 5 mg | 11.417 |
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Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine
Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data. (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Intervention | Nanogram per milliliter (ng/mL) (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 219.9 |
Part 1: Levocetirizine IRT 5 mg | 235.4 |
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Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine
Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Per hour (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 0.07891 |
Part 1: Levocetirizine IRT 5 mg | 0.08113 |
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Part 1: Change From Baseline in Reticulocytes
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Percentage of reticulocytes (Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | -0.0001 |
Part 1: Levocetirizine IRT 5 mg | 0.0004 |
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Part 1: Change From Baseline in Red Blood Cell Count
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Trillion cells per liter (Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 0.078 |
Part 1: Levocetirizine IRT 5 mg | 0.080 |
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Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine
Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose
Intervention | Hours*nanogram per milliliter (Hr*ng/mL) (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 1758.5 |
Part 1: Levocetirizine IRT 5 mg | 1803.2 |
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Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | Micromoles per liter (UMOL/L) (Mean) |
---|
| Direct bilirubin | Total bilirubin | Creatinine | Uric acid |
---|
Part 1: Levocetirizine IRT 5 mg | 0.356 | -1.710 | -1.9890 | 23.2963 |
Part 1: Levocetirizine ODT 5 mg | 0.214 | 0.143 | -1.9522 | 21.0658 |
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Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hr*ng/mL (Geometric Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 1812.9 |
Part 1: Levocetirizine IRT 5 mg | 1852.5 |
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Part 1: Change From Baseline in Amylase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Units per liter (U/L) (Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | 6.3 |
Part 1: Levocetirizine IRT 5 mg | 7.2 |
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Part 1: Change From Baseline in Mean Corpuscle Hemoglobin
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Picograms (Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | -0.04 |
Part 1: Levocetirizine IRT 5 mg | -0.03 |
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Part 1: Change From Baseline in Mean Corpuscle Volume
Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
Intervention | Femtoliters (Mean) |
---|
Part 1: Levocetirizine ODT 5 mg | -0.6 |
Part 1: Levocetirizine IRT 5 mg | -0.5 |
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Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels
Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03555890)
Timeframe: Baseline (Day 1, Pre-dose) and 48 hours post-dose
,
Intervention | International units per liter (IU/L) (Mean) |
---|
| Alkaline phosphatase | Alanine amino transferase | Aspartate amino transferase | Creatine kinase | Gamma glutamyl transferase | Lactate dehydrogenase |
---|
Part 1: Levocetirizine IRT 5 mg | -1.6 | 1.0 | -0.3 | -13.2 | -0.5 | -8.8 |
Part 1: Levocetirizine ODT 5 mg | -0.8 | 0.5 | -0.1 | -10.0 | -0.6 | -11.0 |
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Part 2: Urine Specific Gravity
Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | Ratio (Mean) |
---|
| Pre-dose | 48 hours |
---|
Part 2: Levocetirizine IRT 5 mg | 1.0179 | 1.0159 |
Part 2: Levocetirizine ODT 5 mg | 1.0156 | 1.0160 |
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Part 2: Urine Potential of Hydrogen (pH)
Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | pH (Mean) |
---|
| Pre-dose | 48 hours |
---|
Part 2: Levocetirizine IRT 5 mg | 6.11 | 6.00 |
Part 2: Levocetirizine ODT 5 mg | 6.20 | 6.09 |
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Part 2: Number of Participants With Urinalysis Results by Dipstick Method
Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented. (NCT03555890)
Timeframe: Pre-dose (Day 1) and 48 hours post-dose
,
Intervention | Participants (Count of Participants) |
---|
| Bilirubin, Pre-dose, negative | Bilirubin, 48 hours, negative | Occult blood, Pre-dose, negative | Occult blood, 48 hours, negative | Occult blood, 48 hours, trace | Glucose, Pre-dose, negative | Glucose, 48 hours, negative | Ketones, Pre-dose, negative | Ketones, Pre-dose, positive (1+) | Ketones, 48 hours, negative | Protein, Pre-dose, negative | Protein, 48 hours, negative | Urobilinogen, Pre-dose, trace | Urobilinogen, 48 hours, trace |
---|
Part 2: Levocetirizine IRT 5 mg | 47 | 47 | 47 | 47 | 0 | 47 | 47 | 46 | 1 | 47 | 47 | 47 | 47 | 47 |
Part 2: Levocetirizine ODT 5 mg | 48 | 48 | 48 | 47 | 1 | 48 | 48 | 48 | 0 | 48 | 48 | 48 | 48 | 48 |
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Part 2: AUC(0-inf) of Levocetirizine
Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher). (NCT03555890)
Timeframe: Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose
Intervention | Hr*ng/mL (Geometric Mean) |
---|
Part 2: Levocetirizine ODT 5 mg | 1869.5 |
Part 2: Levocetirizine IRT 5 mg | 1900.2 |
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