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A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01918033
Recruitment Status : Completed
First Posted : August 7, 2013
Results First Posted : August 15, 2014
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Perennial Allergic Rhinitis
Interventions Drug: Desloratadine 5 mg
Drug: Placebo
Enrollment 608
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks Participants receive two placebo tablets orally once daily for up to 2 weeks
Period Title: Overall Study
Started 203 203 202
Treated 202 [1] 203 201 [1]
Completed 198 201 199
Not Completed 5 2 3
Reason Not Completed
Adverse Event             1             0             2
Lost to Follow-up             0             1             0
Protocol Violation             2             0             1
Withdrawal by Subject             2             1             0
[1]
One randomized participant did not receive study drug.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo Total
Hide Arm/Group Description Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks Participants receive two placebo tablets orally once daily for up to 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 203 203 202 608
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 203 participants 202 participants 608 participants
34.3  (13.1) 33.7  (11.9) 34.7  (12.6) 34.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 203 participants 202 participants 608 participants
Female
116
  57.1%
105
  51.7%
121
  59.9%
342
  56.3%
Male
87
  42.9%
98
  48.3%
81
  40.1%
266
  43.8%
1.Primary Outcome
Title Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2
Hide Description The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.
Time Frame Baseline and Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
-1.96
(-2.25 to -1.67)
-1.94
(-2.23 to -1.65)
-1.87
(-2.16 to -1.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in Least Squares (LS) Means
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.49 to 0.31
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.707
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.48 to 0.32
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Week 2
2.Primary Outcome
Title Number of Participants Experiencing an Adverse Event (AE)
Hide Description An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.
Time Frame Up to Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Measure Type: Number
Unit of Measure: Participants
27 29 20
3.Primary Outcome
Title Number of Participants Discontinuing Study Drug Due to an AE
Hide Description An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.
Time Frame Up to Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ASaT population consisted of all participants who received at least one dose of study drug.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Measure Type: Number
Unit of Measure: Participants
1 0 2
4.Secondary Outcome
Title Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1
Hide Description The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.
Time Frame Baseline and Day 3, Week 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Change from Baseline (BL) at Day 3
-1.12
(-1.38 to -0.86)
-1.11
(-1.37 to -0.85)
-0.63
(-0.89 to -0.37)
Change from BL at Week 1
-1.39
(-1.68 to -1.09)
-1.39
(-1.69 to -1.10)
-1.48
(-1.78 to -1.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.84 to -0.11
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Day 3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.82 to -0.10
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Day 3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.29 to 0.53
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Week 1
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.33 to 0.50
Estimation Comments Difference in LS Means for Change from Baseline in TNSS at Week 1
5.Secondary Outcome
Title Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Hide Description The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Sneezing: Change from BL at Day 3
-0.21
(-0.30 to -0.13)
-0.29
(-0.38 to -0.20)
-0.13
(-0.21 to -0.04)
Sneezing: Change from BL at Week 1
-0.27
(-0.36 to -0.17)
-0.36
(-0.45 to -0.27)
-0.38
(-0.47 to -0.29)
Sneezing: Change from BL at Week 2
-0.44
(-0.52 to -0.35)
-0.51
(-0.59 to -0.42)
-0.40
(-0.49 to -0.32)
Rhinorrhea: Change from BL at Day 3
-0.37
(-0.47 to -0.28)
-0.32
(-0.41 to -0.22)
-0.24
(-0.33 to -0.15)
Rhinorrhea: Change from BL at Week 1
-0.39
(-0.49 to -0.29)
-0.38
(-0.48 to -0.28)
-0.44
(-0.54 to -0.34)
Rhinorrhea: Change from BL at Week 2
-0.57
(-0.67 to -0.47)
-0.53
(-0.63 to -0.43)
-0.56
(-0.66 to -0.46)
Nasal Congestion: Change from BL at Day 3
-0.22
(-0.30 to -0.13)
-0.17
(-0.26 to -0.09)
-0.13
(-0.22 to -0.04)
Nasal Congestion: Change from BL at Week 1
-0.28
(-0.38 to -0.18)
-0.22
(-0.32 to -0.13)
-0.32
(-0.42 to -0.23)
Nasal Congestion: Change from BL at Week 2
-0.33
(-0.43 to -0.23)
-0.33
(-0.43 to -0.23)
-0.37
(-0.47 to -0.27)
Nasal Itching: Change from BL at Day 3
-0.32
(-0.42 to -0.22)
-0.33
(-0.43 to -0.23)
-0.15
(-0.25 to -0.05)
Nasal Itching: Change from BL at Week 1
-0.44
(-0.55 to -0.33)
-0.44
(-0.55 to -0.34)
-0.35
(-0.45 to -0.24)
Nasal Itching: Change from BL at Week 2
-0.63
(-0.74 to -0.53)
-0.58
(-0.68 to -0.48)
-0.52
(-0.62 to -0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.15 to 0.08
Estimation Comments Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.22 to 0.01
Estimation Comments Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.15 to 0.13
Estimation Comments Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.627
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.10 to 0.17
Estimation Comments Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.09 to 0.18
Estimation Comments Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.10 to 0.18
Estimation Comments Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.25 to 0.03
Estimation Comments Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.20 to 0.08
Estimation Comments Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2
6.Secondary Outcome
Title Change From Baseline in Nasal Finding Score Assessed by the Investigator
Hide Description The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Swelling of INCM: Change from BL at Day 3
-0.23
(-0.32 to -0.14)
-0.17
(-0.26 to -0.08)
-0.13
(-0.22 to -0.05)
Swelling of INCM: Change from BL at Week 1
-0.35
(-0.44 to -0.25)
-0.31
(-0.40 to -0.21)
-0.34
(-0.43 to -0.24)
Swelling of INCM: Change from BL at Week 2
-0.38
(-0.48 to -0.28)
-0.34
(-0.44 to -0.24)
-0.32
(-0.41 to -0.22)
Coloring of INCM: Change from BL at Day 3
-0.27
(-0.37 to -0.16)
-0.26
(-0.36 to -0.15)
-0.26
(-0.36 to -0.15)
Coloring of INCM: Change from BL at Week 1
-0.35
(-0.47 to -0.24)
-0.38
(-0.49 to -0.27)
-0.40
(-0.51 to -0.28)
Coloring of INCM: Change from BL at Week 2
-0.48
(-0.60 to -0.36)
-0.48
(-0.60 to -0.37)
-0.45
(-0.57 to -0.33)
NDP: Change from BL at Day 3
-0.23
(-0.32 to -0.14)
-0.24
(-0.32 to -0.15)
-0.18
(-0.27 to -0.09)
NDP: Change from BL at Week 1
-0.33
(-0.42 to -0.24)
-0.36
(-0.45 to -0.26)
-0.41
(-0.50 to -0.31)
NDP: Change from BL at Week 2
-0.41
(-0.51 to -0.32)
-0.38
(-0.48 to -0.29)
-0.44
(-0.54 to -0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.20 to 0.07
Estimation Comments Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.16 to 0.11
Estimation Comments Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.725
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.19 to 0.13
Estimation Comments Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.19 to 0.13
Estimation Comments Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.680
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.10 to 0.16
Estimation Comments Difference in LS Means for Change From Baseline in NDP at Week 2
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.373
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.07 to 0.19
Estimation Comments Difference in LS Means for Change From Baseline in NDP at Week 2
7.Secondary Outcome
Title Change From Baseline in Eye Symptom Score Assessed by the Investigator
Hide Description The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Change from BL at Day 3
-0.17
(-0.27 to -0.08)
-0.24
(-0.34 to -0.15)
-0.13
(-0.22 to -0.04)
Change from BL at Week 1
-0.28
(-0.38 to -0.18)
-0.35
(-0.44 to -0.25)
-0.26
(-0.36 to -0.16)
Change from BL at Week 2
-0.38
(-0.48 to -0.28)
-0.44
(-0.54 to -0.34)
-0.37
(-0.46 to -0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.849
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.14 to 0.12
Estimation Comments Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.260
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.20 to 0.06
Estimation Comments Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2
8.Secondary Outcome
Title Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
Hide Description The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.
Time Frame Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 200 203 201
Measure Type: Number
Unit of Measure: Participants
Day 3 (n=199, 201, 200) 67 61 53
Week 1 (n=200, 203, 201) 72 83 91
Week 2 (n=200, 203, 201) 96 93 106
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.826
Confidence Interval (2-Sided) 95%
0.558 to 1.223
Estimation Comments Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.510 to 1.116
Estimation Comments Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.
9.Secondary Outcome
Title Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
Hide Description The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Change from BL at Day 3
-0.18
(-0.26 to -0.10)
-0.19
(-0.27 to -0.12)
-0.07
(-0.15 to 0.00)
Change from BL at Week 1
-0.22
(-0.30 to -0.13)
-0.21
(-0.29 to -0.12)
-0.20
(-0.28 to -0.11)
Change from BL at Week 2
-0.25
(-0.34 to -0.16)
-0.29
(-0.38 to -0.20)
-0.27
(-0.36 to -0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.09 to 0.14
Estimation Comments Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.782
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.13 to 0.10
Estimation Comments Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2
10.Secondary Outcome
Title Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Hide Description Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Sneezing: Change from BL at Day 3
-0.27
(-0.36 to -0.18)
-0.32
(-0.41 to -0.23)
-0.23
(-0.32 to -0.13)
Sneezing: Change from BL at Week 1
-0.38
(-0.48 to -0.29)
-0.40
(-0.49 to -0.30)
-0.30
(-0.39 to -0.20)
Sneezing: Change from BL at Week 2
-0.43
(-0.54 to -0.32)
-0.45
(-0.55 to -0.35)
-0.33
(-0.44 to -0.23)
Rhinorrhea: Change from BL at Day 3
-0.20
(-0.30 to -0.11)
-0.29
(-0.39 to -0.19)
-0.17
(-0.27 to -0.08)
Rhinorrhea: Change from BL at Week 1
-0.29
(-0.39 to -0.18)
-0.36
(-0.46 to -0.26)
-0.34
(-0.44 to -0.23)
Rhinorrhea: Change from BL at Week 2
-0.33
(-0.45 to -0.22)
-0.38
(-0.50 to -0.27)
-0.45
(-0.57 to -0.34)
Nasal Congestion: Change from BL at Day 3
-0.18
(-0.28 to -0.09)
-0.17
(-0.27 to -0.08)
-0.18
(-0.28 to -0.09)
Nasal Congestion: Change from BL at Week 1
-0.23
(-0.33 to -0.13)
-0.24
(-0.34 to -0.14)
-0.25
(-0.35 to -0.15)
Nasal Congestion: Change from BL at Week 2
-0.23
(-034 to -0.12)
-0.26
(-0.37 to -0.15)
-0.32
(-0.43 to -0.20)
Nasal Itching: Change from BL at Day 3
-0.29
(-0.39 to -0.19)
-0.35
(-0.45 to -0.25)
-0.22
(-0.33 to -0.12)
Nasal Itching: Change from BL at Week 1
-0.40
(-0.51 to -0.30)
-0.42
(-0.53 to -0.32)
-0.39
(-0.50 to -0.29)
Nasal Itching: Change from BL at Week 2
-0.52
(-0.64 to -0.40)
-0.47
(-0.59 to -0.36)
-0.44
(-0.56 to -0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.24 to 0.04
Estimation Comments Difference in LS Means for Change from Baseline in Sneezing at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.26 to 0.02
Estimation Comments Difference in LS Means for Change from Baseline in Sneezing at Week 2
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.04 to 0.27
Estimation Comments Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.375
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.08 to 0.22
Estimation Comments Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.08
Confidence Interval (2-Sided) 95%
-0.07 to 0.24
Estimation Comments Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.490
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.10 to 0.21
Estimation Comments Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.23 to 0.08
Estimation Comments Difference in LS Means for Change from Baseline in Nasal Itching at Week 2
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.699
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.19 to 0.13
Estimation Comments Difference in LS Means for Change from Baseline in Nasal Itching at Week 2
11.Secondary Outcome
Title Change From Baseline in Eye Symptom Score Reported in Participant Diaries
Hide Description Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.
Time Frame Baseline and Day 3, Week 1, Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description:
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Participants receive two placebo tablets orally once daily for up to 2 weeks
Overall Number of Participants Analyzed 202 203 201
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Change from BL at Day 3
-0.28
(-0.38 to -0.19)
-0.25
(-0.34 to -0.15)
-0.20
(-0.30 to -0.11)
Change from BL at Week 1
-0.31
(-0.40 to -0.21)
-0.33
(-0.43 to -0.24)
-0.26
(-0.35 to -0.16)
Change from BL at Week 2
-0.33
(-0.44 to -0.22)
-0.35
(-0.45 to -0.24)
-0.27
(-0.38 to -0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Desloratadine 5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.20 to 0.08
Estimation Comments Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Desloratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.281
Comments [Not Specified]
Method Constrained Longitudinal Data Analysis
Comments Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.22 to 0.06
Estimation Comments Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2
Time Frame Up to 2 weeks after last dose of study drug (up to 4 weeks)
Adverse Event Reporting Description The population consisted of all participants who received at least one dose of study drug.
 
Arm/Group Title Desloratadine 5 mg Desloratadine 10 mg Placebo
Hide Arm/Group Description Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks Participants receive two placebo tablets orally once daily for up to 2 weeks
All-Cause Mortality
Desloratadine 5 mg Desloratadine 10 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desloratadine 5 mg Desloratadine 10 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/202 (0.50%)      0/203 (0.00%)      0/201 (0.00%)    
Nervous system disorders       
Epilepsy  1  1/202 (0.50%)  1 0/203 (0.00%)  0 0/201 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desloratadine 5 mg Desloratadine 10 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/202 (5.45%)      17/203 (8.37%)      9/201 (4.48%)    
Infections and infestations       
Nasphopharyngitis  1  11/202 (5.45%)  12 17/203 (8.37%)  17 9/201 (4.48%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01918033     History of Changes
Other Study ID Numbers: 4117-200
132244 ( Registry Identifier: JAPIC-CTI )
First Submitted: August 5, 2013
First Posted: August 7, 2013
Results First Submitted: July 24, 2014
Results First Posted: August 15, 2014
Last Update Posted: November 15, 2018