Trial Outcomes & Findings for A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200) (NCT NCT01918033)
NCT ID: NCT01918033
Last Updated: 2024-06-18
Results Overview
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.
COMPLETED
PHASE3
608 participants
Baseline and Week 2
2024-06-18
Participant Flow
Participant milestones
| Measure |
Desloratadine 5 mg
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
203
|
203
|
202
|
|
Overall Study
Treated
|
202
|
203
|
201
|
|
Overall Study
COMPLETED
|
198
|
201
|
199
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
3
|
Reasons for withdrawal
| Measure |
Desloratadine 5 mg
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
Baseline characteristics by cohort
| Measure |
Desloratadine 5 mg
n=203 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=202 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
Total
n=608 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
33.7 Years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
34.7 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
342 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2
|
-1.96 Score on a Scale
95% Confidence Interval 2.21 • Interval -2.25 to -1.67
|
-1.94 Score on a Scale
95% Confidence Interval 2.21 • Interval -2.23 to -1.65
|
-1.87 Score on a Scale
95% Confidence Interval 2.34 • Interval -2.16 to -1.58
|
PRIMARY outcome
Timeframe: Up to Week 4Population: The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
27 Participants
|
29 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Up to Week 2Population: The ASaT population consisted of all participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Number of Participants Discontinuing Study Drug Due to an AE
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1
Change from Baseline (BL) at Day 3
|
-1.12 Score on a Scale
95% Confidence Interval 2.05 • Interval -1.38 to -0.86
|
-1.11 Score on a Scale
95% Confidence Interval 2.02 • Interval -1.37 to -0.85
|
-0.63 Score on a Scale
95% Confidence Interval 2.03 • Interval -0.89 to -0.37
|
|
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1
Change from BL at Week 1
|
-1.39 Score on a Scale
95% Confidence Interval 2.41 • Interval -1.68 to -1.09
|
-1.39 Score on a Scale
95% Confidence Interval 2.28 • Interval -1.69 to -1.1
|
-1.48 Score on a Scale
95% Confidence Interval 2.32 • Interval -1.78 to -1.18
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Sneezing: Change from BL at Day 3
|
-0.21 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.3 to -0.13
|
-0.29 Score on a Scale
95% Confidence Interval 0.67 • Interval -0.38 to -0.2
|
-0.13 Score on a Scale
95% Confidence Interval 0.65 • Interval -0.21 to -0.04
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Sneezing: Change from BL at Week 1
|
-0.27 Score on a Scale
95% Confidence Interval 0.78 • Interval -0.36 to -0.17
|
-0.36 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.45 to -0.27
|
-0.38 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.47 to -0.29
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Sneezing: Change from BL at Week 2
|
-0.44 Score on a Scale
95% Confidence Interval 0.74 • Interval -0.52 to -0.35
|
-0.51 Score on a Scale
95% Confidence Interval 0.69 • Interval -0.59 to -0.42
|
-0.40 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.49 to -0.32
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Rhinorrhea: Change from BL at Day 3
|
-0.37 Score on a Scale
95% Confidence Interval 0.66 • Interval -0.47 to -0.28
|
-0.32 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.41 to -0.22
|
-0.24 Score on a Scale
95% Confidence Interval 0.74 • Interval -0.33 to -0.15
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Rhinorrhea: Change from BL at Week 1
|
-0.39 Score on a Scale
95% Confidence Interval 0.77 • Interval -0.49 to -0.29
|
-0.38 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.48 to -0.28
|
-0.44 Score on a Scale
95% Confidence Interval 0.78 • Interval -0.54 to -0.34
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Rhinorrhea: Change from BL at Week 2
|
-0.57 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.67 to -0.47
|
-0.53 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.63 to -0.43
|
-0.56 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.66 to -0.46
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Congestion: Change from BL at Day 3
|
-0.22 Score on a Scale
95% Confidence Interval 0.68 • Interval -0.3 to -0.13
|
-0.17 Score on a Scale
95% Confidence Interval 0.68 • Interval -0.26 to -0.09
|
-0.13 Score on a Scale
95% Confidence Interval 0.65 • Interval -0.22 to -0.04
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Congestion: Change from BL at Week 1
|
-0.28 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.38 to -0.18
|
-0.22 Score on a Scale
95% Confidence Interval 0.70 • Interval -0.32 to -0.13
|
-0.32 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.42 to -0.23
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Congestion: Change from BL at Week 2
|
-0.33 Score on a Scale
95% Confidence Interval 0.78 • Interval -0.43 to -0.23
|
-0.33 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.43 to -0.23
|
-0.37 Score on a Scale
95% Confidence Interval 0.77 • Interval -0.47 to -0.27
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Itching: Change from BL at Week 1
|
-0.44 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.55 to -0.33
|
-0.44 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.55 to -0.34
|
-0.35 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.45 to -0.24
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Itching: Change from BL at Week 2
|
-0.63 Score on a Scale
95% Confidence Interval 0.91 • Interval -0.74 to -0.53
|
-0.58 Score on a Scale
95% Confidence Interval 0.86 • Interval -0.68 to -0.48
|
-0.52 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.62 to -0.42
|
|
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
Nasal Itching: Change from BL at Day 3
|
-0.32 Score on a Scale
95% Confidence Interval 0.79 • Interval -0.42 to -0.22
|
-0.33 Score on a Scale
95% Confidence Interval 0.82 • Interval -0.43 to -0.23
|
-0.15 Score on a Scale
95% Confidence Interval 0.80 • Interval -0.25 to -0.05
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Swelling of INCM: Change from BL at Day 3
|
-0.23 Score on a Scale
95% Confidence Interval 0.70 • Interval -0.32 to -0.14
|
-0.17 Score on a Scale
95% Confidence Interval 0.68 • Interval -0.26 to -0.08
|
-0.13 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.22 to -0.05
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Swelling of INCM: Change from BL at Week 2
|
-0.38 Score on a Scale
95% Confidence Interval 0.74 • Interval -0.48 to -0.28
|
-0.34 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.44 to -0.24
|
-0.32 Score on a Scale
95% Confidence Interval 0.82 • Interval -0.41 to -0.22
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Coloring of INCM: Change from BL at Week 1
|
-0.35 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.47 to -0.24
|
-0.38 Score on a Scale
95% Confidence Interval 0.89 • Interval -0.49 to -0.27
|
-0.40 Score on a Scale
95% Confidence Interval 0.91 • Interval -0.51 to -0.28
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Coloring of INCM: Change from BL at Week 2
|
-0.48 Score on a Scale
95% Confidence Interval 0.97 • Interval -0.6 to -0.36
|
-0.48 Score on a Scale
95% Confidence Interval 0.85 • Interval -0.6 to -0.37
|
-0.45 Score on a Scale
95% Confidence Interval 0.96 • Interval -0.57 to -0.33
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
NDP: Change from BL at Day 3
|
-0.23 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.32 to -0.14
|
-0.24 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.32 to -0.15
|
-0.18 Score on a Scale
95% Confidence Interval 0.65 • Interval -0.27 to -0.09
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
NDP: Change from BL at Week 1
|
-0.33 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.42 to -0.24
|
-0.36 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.45 to -0.26
|
-0.41 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.5 to -0.31
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
NDP: Change from BL at Week 2
|
-0.41 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.51 to -0.32
|
-0.38 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.48 to -0.29
|
-0.44 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.54 to -0.35
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Swelling of INCM: Change from BL at Week 1
|
-0.35 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.44 to -0.25
|
-0.31 Score on a Scale
95% Confidence Interval 0.69 • Interval -0.4 to -0.21
|
-0.34 Score on a Scale
95% Confidence Interval 0.78 • Interval -0.43 to -0.24
|
|
Change From Baseline in Nasal Finding Score Assessed by the Investigator
Coloring of INCM: Change from BL at Day 3
|
-0.27 Score on a Scale
95% Confidence Interval 0.86 • Interval -0.37 to -0.16
|
-0.26 Score on a Scale
95% Confidence Interval 0.79 • Interval -0.36 to -0.15
|
-0.26 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.36 to -0.15
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Eye Symptom Score Assessed by the Investigator
Change from BL at Day 3
|
-0.17 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.27 to -0.08
|
-0.24 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.34 to -0.15
|
-0.13 Score on a Scale
95% Confidence Interval 0.74 • Interval -0.22 to -0.04
|
|
Change From Baseline in Eye Symptom Score Assessed by the Investigator
Change from BL at Week 1
|
-0.28 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.38 to -0.18
|
-0.35 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.44 to -0.25
|
-0.26 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.36 to -0.16
|
|
Change From Baseline in Eye Symptom Score Assessed by the Investigator
Change from BL at Week 2
|
-0.38 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.48 to -0.28
|
-0.44 Score on a Scale
95% Confidence Interval 0.77 • Interval -0.54 to -0.34
|
-0.37 Score on a Scale
95% Confidence Interval 0.79 • Interval -0.46 to -0.27
|
SECONDARY outcome
Timeframe: Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=200 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
Day 3 (n=199, 201, 200)
|
67 Participants
|
61 Participants
|
53 Participants
|
|
Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
Week 1 (n=200, 203, 201)
|
72 Participants
|
83 Participants
|
91 Participants
|
|
Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
Week 2 (n=200, 203, 201)
|
96 Participants
|
93 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
Change from BL at Day 3
|
-0.18 Score on a Scale
95% Confidence Interval 0.63 • Interval -0.26 to -0.1
|
-0.19 Score on a Scale
95% Confidence Interval 0.58 • Interval -0.27 to -0.12
|
-0.07 Score on a Scale
95% Confidence Interval 0.62 • Interval -0.15 to 0.0
|
|
Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
Change from BL at Week 1
|
-0.22 Score on a Scale
95% Confidence Interval 0.69 • Interval -0.3 to -0.13
|
-0.21 Score on a Scale
95% Confidence Interval 0.68 • Interval -0.29 to -0.12
|
-0.20 Score on a Scale
95% Confidence Interval 0.64 • Interval -0.28 to -0.11
|
|
Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
Change from BL at Week 2
|
-0.25 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.34 to -0.16
|
-0.29 Score on a Scale
95% Confidence Interval 0.69 • Interval -0.38 to -0.2
|
-0.27 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.36 to -0.19
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Rhinorrhea: Change from BL at Week 1
|
-0.29 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.39 to -0.18
|
-0.36 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.46 to -0.26
|
-0.34 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.44 to -0.23
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Rhinorrhea: Change from BL at Week 2
|
-0.33 Score on a Scale
95% Confidence Interval 0.85 • Interval -0.45 to -0.22
|
-0.38 Score on a Scale
95% Confidence Interval 0.86 • Interval -0.5 to -0.27
|
-0.45 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.57 to -0.34
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Sneezing: Change from BL at Day 3
|
-0.27 Score on a Scale
95% Confidence Interval 0.72 • Interval -0.36 to -0.18
|
-0.32 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.41 to -0.23
|
-0.23 Score on a Scale
95% Confidence Interval 0.79 • Interval -0.32 to -0.13
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Sneezing: Change from BL at Week 1
|
-0.38 Score on a Scale
95% Confidence Interval 0.72 • Interval -0.48 to -0.29
|
-0.40 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.49 to -0.3
|
-0.30 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.39 to -0.2
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Sneezing: Change from BL at Week 2
|
-0.43 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.54 to -0.32
|
-0.45 Score on a Scale
95% Confidence Interval 0.86 • Interval -0.55 to -0.35
|
-0.33 Score on a Scale
95% Confidence Interval 0.81 • Interval -0.44 to -0.23
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Rhinorrhea: Change from BL at Day 3
|
-0.20 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.3 to -0.11
|
-0.29 Score on a Scale
95% Confidence Interval 0.74 • Interval -0.39 to -0.19
|
-0.17 Score on a Scale
95% Confidence Interval 0.80 • Interval -0.27 to -0.08
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Congestion: Change from BL at Day 3
|
-0.18 Score on a Scale
95% Confidence Interval 0.71 • Interval -0.28 to -0.09
|
-0.17 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.27 to -0.08
|
-0.18 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.28 to -0.09
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Congestion: Change from BL at Week 1
|
-0.23 Score on a Scale
95% Confidence Interval 0.69 • Interval -0.33 to -0.13
|
-0.24 Score on a Scale
95% Confidence Interval 0.79 • Interval -0.34 to -0.14
|
-0.25 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.35 to -0.15
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Congestion: Change from BL at Week 2
|
-0.23 Score on a Scale
95% Confidence Interval 0.76 • Interval -34.0 to -0.12
|
-0.26 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.37 to -0.15
|
-0.32 Score on a Scale
95% Confidence Interval 0.78 • Interval -0.43 to -0.2
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Itching: Change from BL at Day 3
|
-0.29 Score on a Scale
95% Confidence Interval 0.76 • Interval -0.39 to -0.19
|
-0.35 Score on a Scale
95% Confidence Interval 0.85 • Interval -0.45 to -0.25
|
-0.22 Score on a Scale
95% Confidence Interval 0.77 • Interval -0.33 to -0.12
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Itching: Change from BL at Week 1
|
-0.40 Score on a Scale
95% Confidence Interval 0.88 • Interval -0.51 to -0.3
|
-0.42 Score on a Scale
95% Confidence Interval 0.80 • Interval -0.53 to -0.32
|
-0.39 Score on a Scale
95% Confidence Interval 0.87 • Interval -0.5 to -0.29
|
|
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
Nasal Itching: Change from BL at Week 2
|
-0.52 Score on a Scale
95% Confidence Interval 0.92 • Interval -0.64 to -0.4
|
-0.47 Score on a Scale
95% Confidence Interval 0.90 • Interval -0.59 to -0.36
|
-0.44 Score on a Scale
95% Confidence Interval 0.87 • Interval -0.56 to -0.33
|
SECONDARY outcome
Timeframe: Baseline and Day 3, Week 1, Week 2Population: 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.
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.
Outcome measures
| Measure |
Desloratadine 5 mg
n=202 Participants
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 Participants
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 Participants
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Change From Baseline in Eye Symptom Score Reported in Participant Diaries
Change from BL at Day 3
|
-0.28 Score on a Scale
95% Confidence Interval 0.73 • Interval -0.38 to -0.19
|
-0.25 Score on a Scale
95% Confidence Interval 0.72 • Interval -0.34 to -0.15
|
-0.20 Score on a Scale
95% Confidence Interval 0.83 • Interval -0.3 to -0.11
|
|
Change From Baseline in Eye Symptom Score Reported in Participant Diaries
Change from BL at Week 1
|
-0.31 Score on a Scale
95% Confidence Interval 0.82 • Interval -0.4 to -0.21
|
-0.33 Score on a Scale
95% Confidence Interval 0.75 • Interval -0.43 to -0.24
|
-0.26 Score on a Scale
95% Confidence Interval 0.80 • Interval -0.35 to -0.16
|
|
Change From Baseline in Eye Symptom Score Reported in Participant Diaries
Change from BL at Week 2
|
-0.33 Score on a Scale
95% Confidence Interval 0.80 • Interval -0.44 to -0.22
|
-0.35 Score on a Scale
95% Confidence Interval 0.82 • Interval -0.45 to -0.24
|
-0.27 Score on a Scale
95% Confidence Interval 0.84 • Interval -0.38 to -0.17
|
Adverse Events
Desloratadine 5 mg
Desloratadine 10 mg
Placebo
Serious adverse events
| Measure |
Desloratadine 5 mg
n=202 participants at risk
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 participants at risk
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 participants at risk
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.50%
1/202 • Number of events 1 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/203 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
0.00%
0/201 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Desloratadine 5 mg
n=202 participants at risk
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
|
Desloratadine 10 mg
n=203 participants at risk
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
|
Placebo
n=201 participants at risk
Participants receive two placebo tablets orally once daily for up to 2 weeks
|
|---|---|---|---|
|
Infections and infestations
Nasphopharyngitis
|
5.4%
11/202 • Number of events 12 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
8.4%
17/203 • Number of events 17 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
4.5%
9/201 • Number of events 10 • Up to 2 weeks after last dose of study drug (up to 4 weeks)
The population consisted of all participants who received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER