Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

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: NCT03855228
Recruitment Status : Completed
First Posted : February 26, 2019
Results First Posted : July 26, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Rhinitis, Allergic
Interventions Drug: Mometasone furoate nasal spray (MFNS)
Drug: Loratadine
Drug: Placebo nasal spray
Drug: Placebo tablet
Enrollment 704
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description Daily administration of 200 μg of Mometasone Furoate Nasal Spray (MFNS) plus oral dose of 10 mg loratadine tablet. Daily administration of 200 μg of MFNS plus oral placebo tablet. Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. Daily administration of placebo nasal spray plus oral placebo tablet.
Period Title: Overall Study
Started 169 176 182 177
Treated 169 176 181 [1] 176 [1]
Completed 166 167 174 158
Not Completed 3 9 8 19
Reason Not Completed
Adverse Event             2             4             4             8
Treatment Failure             1             2             1             8
Lost to Follow-up             0             0             0             1
Protocol Violation             0             1             2             1
Did Not Meet Entry Requirements             0             2             1             1
[1]
1 participant immediately dropped out prior to starting study intervention.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo Total
Hide Arm/Group Description Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet. Daily administration of 200 μg of MFNS plus oral placebo tablet. Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. Daily administration of placebo nasal spray plus oral placebo tablet. Total of all reporting groups
Overall Number of Baseline Participants 169 176 181 176 702
Hide Baseline Analysis Population Description
Includes all randomized participants who received ≥1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants 176 participants 181 participants 176 participants 702 participants
25.6  (13.1) 25.6  (13.2) 25.2  (12.6) 25.6  (13.3) 25.5  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 176 participants 181 participants 176 participants 702 participants
Female
85
  50.3%
89
  50.6%
91
  50.3%
85
  48.3%
350
  49.9%
Male
84
  49.7%
87
  49.4%
90
  49.7%
91
  51.7%
352
  50.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 176 participants 181 participants 176 participants 702 participants
Hispanic or Latino
7
   4.1%
9
   5.1%
7
   3.9%
7
   4.0%
30
   4.3%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
162
  95.9%
167
  94.9%
174
  96.1%
169
  96.0%
672
  95.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 176 participants 181 participants 176 participants 702 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.2%
0
   0.0%
3
   1.7%
2
   1.1%
7
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   5.9%
12
   6.8%
7
   3.9%
12
   6.8%
41
   5.8%
White
150
  88.8%
154
  87.5%
164
  90.6%
154
  87.5%
622
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   4.1%
10
   5.7%
7
   3.9%
8
   4.5%
32
   4.6%
1.Primary Outcome
Title Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Hide Description

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.

CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time Frame Baseline and days 1 through 15 (average of 15 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 166 175 165
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 7.9  (2.2) 7.8  (2.2) 7.9  (2.2) 8.0  (2.1)
Change From Baseline Days 1-15 -3.0  (2.6) -2.7  (2.5) -1.9  (2.2) -1.4  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Total Symptom Score (Assessed by Participant)
Hide Description

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.

CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time Frame Baseline and days 1 through 15 (average of 15 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 166 175 165
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 14.3  (4.1) 14.2  (4.4) 14.4  (4.5) 14.6  (4.3)
Change From Baseline Days 1-15 -5.4  (4.8) -4.8  (4.7) -3.8  (4.2) -2.7  (4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
8.7  (1.8) 8.6  (1.8) 8.6  (1.7) 8.8  (1.8)
Change From Baseline Day 15 Number Analyzed 160 participants 159 participants 167 participants 154 participants
-4.4  (3.1) -4.2  (2.8) -3.1  (2.8) -2.8  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
15.9  (3.1) 16.1  (3.4) 15.9  (3.2) 16.2  (3.5)
Change From Baseline Day 15 Number Analyzed 160 participants 159 participants 167 participants 154 participants
-8.2  (5.3) -8.0  (5.1) -6.2  (5.1) -5.4  (5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
8.7  (1.8) 8.6  (1.8) 8.6  (1.7) 8.8  (1.8)
Change From Baseline Day 8 Number Analyzed 165 participants 163 participants 172 participants 162 participants
-3.7  (3.1) -3.6  (2.7) -2.6  (2.6) -2.2  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
15.9  (3.1) 16.1  (3.4) 15.9  (3.2) 16.2  (3.5)
Change From Baseline Day 8 Number Analyzed 165 participants 163 participants 172 participants 162 participants
-7.0  (5.4) -6.9  (4.9) -5.2  (4.6) -4.6  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
2.3  (0.5) 2.3  (0.5) 2.3  (0.5) 2.3  (0.5)
Change From Baseline Day 15 Number Analyzed 160 participants 159 participants 167 participants 154 participants
-0.9  (0.7) -0.9  (0.7) -0.6  (0.8) -0.6  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
Hide Description

The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.

A negative change from baseline indicates a decrease in symptom severity.

Time Frame Baseline and study day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 164 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline Number Analyzed 165 participants 164 participants 172 participants 162 participants
2.3  (0.5) 2.3  (0.5) 2.3  (0.5) 2.3  (0.5)
Change From Baseline Day 8 Number Analyzed 165 participants 163 participants 172 participants 162 participants
-0.8  (0.8) -0.7  (0.7) -0.5  (0.7) -0.5  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments This analysis compares Change From Baseline values.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Response to Therapy on Day 15 (Assessed by Physician)
Hide Description Mean response to therapy based on the participant’s status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
Time Frame Study day 15
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 160 159 167 154
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.8  (1.0) 3.0  (1.0) 3.4  (1.1) 3.4  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Response to Therapy on Day 8 (Assessed by Physician)
Hide Description Mean response to therapy based on the participant’s status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
Time Frame Study day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Arm/Group Title MFNS 200 μg + Loratadine 10 mg MFNS 200 μg Loratadine 10 mg Placebo
Hide Arm/Group Description:
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
Daily administration of 200 μg of MFNS plus oral placebo tablet.
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
Daily administration of placebo nasal spray plus oral placebo tablet.
Overall Number of Participants Analyzed 165 163 172 162
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.0  (1.1) 3.1  (1.0) 3.4  (0.9) 3.6  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, MFNS 200 μg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Loratadine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg + Loratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Loratadine 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MFNS 200 μg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Loratadine 10 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Up to approximately 45 days.
Adverse Event Reporting Description Analysis population includes all randomized participants with at least one post-Baseline evaluation. Adverse event (AE) preferred terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
 
Arm/Group Title MFNS Pus Loratadine MFNS 200 Loratadine Placebo
Hide Arm/Group Description Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet. Daily administration of 200 μg of MFNS plus oral placebo tablet. Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. Daily administration of placebo nasal spray plus oral placebo tablet.
All-Cause Mortality
MFNS Pus Loratadine MFNS 200 Loratadine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)      0/176 (0.00%)      0/181 (0.00%)      0/176 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MFNS Pus Loratadine MFNS 200 Loratadine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/169 (0.00%)      0/176 (0.00%)      0/181 (0.00%)      0/176 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MFNS Pus Loratadine MFNS 200 Loratadine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/169 (13.02%)      22/176 (12.50%)      33/181 (18.23%)      21/176 (11.93%)    
Nervous system disorders         
HEADACHE  1  22/169 (13.02%)  35 22/176 (12.50%)  28 33/181 (18.23%)  41 21/176 (11.93%)  31
1
Term from vocabulary, MedDRA 12.0
Indicates events were collected by systematic assessment
AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
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 Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of Sponsor. The Principal Investigator further agrees to provide thirty (30) days prior to submission for publication or presentation to Sponsor to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03855228     History of Changes
Other Study ID Numbers: C94-145
C94-145 ( Other Identifier: Schering-Plough Corporation Protocol Number )
First Submitted: February 25, 2019
First Posted: February 26, 2019
Results First Submitted: May 29, 2019
Results First Posted: July 26, 2019
Last Update Posted: August 14, 2019