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A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627)

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ClinicalTrials.gov Identifier: NCT01644617
Recruitment Status : Completed
First Posted : July 19, 2012
Results First Posted : February 13, 2017
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
ALK-Abelló A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Interventions Drug: Placebo
Drug: MK-8237 6 DU
Drug: MK-8237 12 DU
Enrollment 124
Recruitment Details Participants must have had a clinical history of allergic rhinitis/rhinoconjunctivitis (with or without asthma) to house dust of 1 year duration or more and determined to be sensitized to Dermatophagoides pteronyssinus and/or Dermatophagoides farina by skin prick test and immunoglobulin E levels. Other inclusion and exclusion criteria applied.
Pre-assignment Details  
Arm/Group Title MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo
Hide Arm/Group Description Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Period Title: Overall Study
Started 42 41 41
Completed 36 36 34
Not Completed 6 5 7
Reason Not Completed
Withdrawal by Subject             3             4             1
Lost to Follow-up             0             1             0
Adverse Event             3             0             6
Arm/Group Title MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo Total
Hide Arm/Group Description Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 42 41 41 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 41 participants 41 participants 124 participants
27.5  (9.2) 26.7  (7.0) 26.6  (6.1) 26.9  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 41 participants 41 participants 124 participants
Female
19
  45.2%
30
  73.2%
17
  41.5%
66
  53.2%
Male
23
  54.8%
11
  26.8%
24
  58.5%
58
  46.8%
1.Primary Outcome
Title Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24
Hide Description The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 36 36 34
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
3.83
(2.94 to 4.72)
5.47
(4.55 to 6.39)
7.45
(6.57 to 8.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Means (LSM)
Estimated Value -3.62
Confidence Interval (2-Sided) 95%
-4.85 to -2.39
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.98
Confidence Interval (2-Sided) 95%
-3.24 to -0.72
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
2.Secondary Outcome
Title Average TNSS During EEC Challenge Session at Week 16
Hide Description The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 39 36 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
4.82
(4.07 to 5.56)
5.67
(4.83 to 6.50)
6.90
(6.13 to 7.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -2.08
Confidence Interval (2-Sided) 95%
-3.14 to -1.03
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.23
Confidence Interval 95%
-2.36 to -0.11
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
3.Secondary Outcome
Title Average TNSS During EEC Challenge Session at Week 8
Hide Description The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
5.34
(4.53 to 6.15)
6.16
(5.55 to 6.78)
6.71
(6.13 to 7.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.37
Confidence Interval (2-Sided) 95%
-2.34 to -0.39
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-1.38 to 0.29
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
4.Secondary Outcome
Title Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24
Hide Description The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 36 36 34
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
4.43
(3.20 to 5.66)
6.62
(5.48 to 7.77)
9.27
(7.98 to 10.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -4.84
Confidence Interval (2-Sided) 95%
-6.59 to -3.09
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -2.65
Confidence Interval (2-Sided) 95%
-4.35 to -0.95
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
5.Secondary Outcome
Title Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16
Hide Description The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 39 36 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
5.95
(4.92 to 6.99)
7.21
(6.05 to 8.37)
8.58
(7.46 to 9.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -2.62
Confidence Interval (2-Sided) 95%
-4.12 to -1.13
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.37
Confidence Interval (2-Sided) 95%
-2.96 to 0.22
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
6.Secondary Outcome
Title Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8
Hide Description The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
6.51
(5.52 to 7.51)
7.65
(6.81 to 8.48)
8.48
(7.56 to 9.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-3.30 to -0.64
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-2.06 to 0.40
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
7.Secondary Outcome
Title Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24
Hide Description The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 36 36 34
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
0.61
(0.21 to 1.00)
1.10
(0.68 to 1.53)
1.87
(1.35 to 2.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.92 to -0.62
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.77
Confidence Interval (2-Sided) 95%
-1.43 to -0.11
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
8.Secondary Outcome
Title Average TOSS During EEC Challenge Session at Week 16
Hide Description The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 39 36 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
1.14
(0.72 to 1.55)
1.54
(1.05 to 2.03)
1.67
(1.22 to 2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.13 to 0.07
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.79 to 0.52
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
9.Secondary Outcome
Title Average TOSS During EEC Challenge Session at Week 8
Hide Description The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
1.18
(0.86 to 1.50)
1.45
(1.08 to 1.83)
1.79
(1.36 to 2.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.14 to -0.09
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.235
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.90 to 0.22
Estimation Comments Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.
10.Secondary Outcome
Title HDM-specific Immunoglobulin E (IgE) Levels at Week 8
Hide Description Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Mean (Standard Deviation)
Unit of Measure: Log 10 kU/L
D. pteronyssinus 1.77  (0.67) 1.64  (0.53) 1.25  (0.54)
D. farinae 1.80  (0.67) 1.69  (0.53) 1.31  (0.55)
11.Secondary Outcome
Title HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Mean (Standard Deviation)
Unit of Measure: Log 10 mg/L
D. pteronyssinus -0.31  (0.40) -0.33  (0.31) -0.57  (0.11)
D. farinae -0.32  (0.47) -0.31  (0.41) -0.62  (0.22)
12.Secondary Outcome
Title Change From Baseline in HDM-specific IgE Levels at Week 8
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Log 10 kU/L
D. pteronyssinus
0.63
(0.51 to 0.75)
0.50
(0.41 to 0.59)
0.08
(0.03 to 0.12)
D. farinae
0.59
(0.48 to 0.70)
0.46
(0.38 to 0.55)
0.07
(0.03 to 0.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. pteronyssinus
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.43 to 0.68
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. pteronyssinus
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.33 to 0.52
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. farinae
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.41 to 0.64
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. farinae
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.30 to 0.48
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
13.Secondary Outcome
Title Change From Baseline in HDM-specific IgG4 Levels at Week 8
Time Frame Time Frame: Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 40 39 39
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Log 10 mg/L
D. pteronyssinus
0.23
(0.13 to 0.33)
0.19
(0.12 to 0.25)
-0.00
(-0.01 to 0.01)
D. farinae
0.32
(0.22 to 0.41)
0.24
(0.16 to 0.32)
-0.01
(-0.03 to 0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. pteronyssinus
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
0.13 to 0.33
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. pteronyssinus
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.12 to 0.25
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. farinae
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.23 to 0.42
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LSM: D. farinae
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.16 to 0.33
Estimation Comments Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.
14.Secondary Outcome
Title Percentage of Participants Who Experienced At Least One Adverse Event (AE)
Hide Description An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
Time Frame From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated including all randomized participants who received at least one dose of study treatment
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 42 41 41
Measure Type: Number
Unit of Measure: Percentage of participants
90.5 87.8 78.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage Versus Placebo
Estimated Value 12.4
Confidence Interval 95%
-3.6 to 28.9
Estimation Comments Analysis based on the Miettinen and Nurminen method
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage Versus Placebo
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
-7.0 to 26.6
Estimation Comments Analysis based on the Miettinen and Nurminen method
15.Secondary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to an AE
Hide Description The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
Time Frame From first dose to last dose of treatment (Up to 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants as Treated including all randomized participants who received at least one dose of study treatment
Arm/Group Title MK-8237 12 DU MK-8237 6 DU Placebo
Hide Arm/Group Description:
Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Overall Number of Participants Analyzed 42 41 41
Measure Type: Number
Unit of Measure: Percentage of Participants
7.1 0.0 14.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-8237 12 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage Versus Placebo
Estimated Value -7.5
Confidence Interval (2-Sided) 95%
-22.6 to 6.7
Estimation Comments Analysis based on the Miettinen and Nurminen method
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-8237 6 DU, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage Versus Placebo
Estimated Value -14.6
Confidence Interval (2-Sided) 95%
-28.5 to -5.4
Estimation Comments Analysis based on the Miettinen and Nurminen method
Time Frame From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)
Adverse Event Reporting Description Adverse events collected for all randomized subjects who received at least one dose of study treatment
 
Arm/Group Title MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo
Hide Arm/Group Description Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks. Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks. Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
All-Cause Mortality
MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/41 (0.00%)      1/41 (2.44%)    
Ear and labyrinth disorders       
Vertigo  1  0/42 (0.00%)  0 0/41 (0.00%)  0 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
MK-8237 12 Development Units (DU) MK-8237 6 DU Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/42 (85.71%)      35/41 (85.37%)      24/41 (58.54%)    
Ear and labyrinth disorders       
Ear pruritus  1  3/42 (7.14%)  3 1/41 (2.44%)  1 0/41 (0.00%)  0
Gastrointestinal disorders       
Dyspepsia  1  4/42 (9.52%)  6 2/41 (4.88%)  2 0/41 (0.00%)  0
Lip swelling  1  8/42 (19.05%)  9 2/41 (4.88%)  2 1/41 (2.44%)  2
Oedema mouth  1  10/42 (23.81%)  10 10/41 (24.39%)  10 0/41 (0.00%)  0
Oral pruritus  1  6/42 (14.29%)  7 6/41 (14.63%)  6 0/41 (0.00%)  0
Infections and infestations       
Influenza  1  3/42 (7.14%)  3 3/41 (7.32%)  5 3/41 (7.32%)  3
Nasopharyngitis  1  12/42 (28.57%)  16 9/41 (21.95%)  11 8/41 (19.51%)  8
Nervous system disorders       
Headache  1  7/42 (16.67%)  9 6/41 (14.63%)  9 8/41 (19.51%)  13
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/42 (7.14%)  3 2/41 (4.88%)  2 1/41 (2.44%)  1
Dyspnoea  1  7/42 (16.67%)  11 8/41 (19.51%)  13 13/41 (31.71%)  22
Oropharyngeal pain  1  4/42 (9.52%)  5 4/41 (9.76%)  4 2/41 (4.88%)  2
Rhinitis allergic  1  5/42 (11.90%)  5 7/41 (17.07%)  8 6/41 (14.63%)  7
Rhinitis seasonal  1  1/42 (2.38%)  1 3/41 (7.32%)  3 2/41 (4.88%)  2
Throat irritation  1  22/42 (52.38%)  26 14/41 (34.15%)  15 0/41 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
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 investigator agrees not to publish or publicly present any interim results without the prior written consent of the sponsor. The Sponsor has the opportunity to review all proposed abstracts, manuscripts, presentations, or data analyses regarding this trial 45 days prior to submission for publication/presentation. The sponsor has the right to review and comment with regard to proprietary information, accuracy, and compliance with FDA regulations.
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: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01644617     History of Changes
Other Study ID Numbers: P07627
2012-001855-38 ( EudraCT Number )
8237-003 ( Other Identifier: Merck Registration Number )
First Submitted: July 17, 2012
First Posted: July 19, 2012
Results First Submitted: December 20, 2016
Results First Posted: February 13, 2017
Last Update Posted: September 15, 2017