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Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)

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: NCT02256553
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : January 18, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Seasonal
Interventions Biological: MK-3641 12 Amb a 1-U (short ragweed extract)
Biological: MK-7243 2800 BAU (Timothy grass extract)
Drug: Rescue Medication
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Period Title: Period I
Started 102
Completed 96
Not Completed 6
Reason Not Completed
Adverse Event             5
Protocol Violation             1
Period Title: Period II
Started 96
Completed 94
Not Completed 2
Reason Not Completed
Adverse Event             1
Subject Moved             1
Period Title: Period III
Started 94
Completed 91
Not Completed 3
Reason Not Completed
Adverse Event             3
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
40.0  (12.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
53
  52.0%
Male
49
  48.0%
1.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Event of Local Swelling
Hide Description Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame During Period I, Period II and Period III (Up to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants population consisted of all participants who received ≥1 dose of study drug.
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description:
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Period I
13.7
(7.7 to 22.0)
Period II
21.6
(14.0 to 30.8)
Period III
14.7
(8.5 to 23.1)
2.Secondary Outcome
Title Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction
Hide Description Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame During Period I, Period II and Period III (Up to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants population consisted of all participants who received ≥1 dose of study drug.
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description:
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Period I
70.6
(60.7 to 79.2)
Period II
68.6
(58.7 to 77.5)
Period III
55.9
(45.7 to 65.7)
3.Secondary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
Hide Description An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.
Time Frame During Period I, Period II and Period III (Up to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants population consisted of all participants who received ≥1 dose of study drug.
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description:
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Period I
4.9
(1.6 to 11.1)
Period II
1.0
(0.0 to 5.3)
Period III
2.9
(0.6 to 8.4)
4.Secondary Outcome
Title Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment
Hide Description Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.
Time Frame During Period I, Period II and Period III (Up to 6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All Treated Participants population consisted of all participants who received ≥1 dose of study drug.
Arm/Group Title MK-3641+MK-7243
Hide Arm/Group Description:
Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
Overall Number of Participants Analyzed 102
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Period I
4.9
(1.6 to 11.1)
Period II
3.9
(1.1 to 9.7)
Period III
1.0
(0.0 to 5.3)
Time Frame Up to 8 weeks
Adverse Event Reporting Description All Treated Participants population consisted of all participants who received ≥1 dose of study drug.
 
Arm/Group Title Period I: MK-7243 Period II: MK-3641+MK-7243 Period III: MK-3641+MK-7243
Hide Arm/Group Description Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III. Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III. Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
All-Cause Mortality
Period I: MK-7243 Period II: MK-3641+MK-7243 Period III: MK-3641+MK-7243
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Period I: MK-7243 Period II: MK-3641+MK-7243 Period III: MK-3641+MK-7243
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      1/96 (1.04%)      0/94 (0.00%)    
Respiratory, thoracic and mediastinal disorders       
Throat irritation  1  0/102 (0.00%)  0 1/96 (1.04%)  1 0/94 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period I: MK-7243 Period II: MK-3641+MK-7243 Period III: MK-3641+MK-7243
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   74/102 (72.55%)      68/96 (70.83%)      55/94 (58.51%)    
Ear and labyrinth disorders       
Ear pruritus  1  34/102 (33.33%)  66 33/96 (34.38%)  68 20/94 (21.28%)  38
Gastrointestinal disorders       
Abdominal pain upper  1  7/102 (6.86%)  8 11/96 (11.46%)  21 6/94 (6.38%)  10
Glossodynia  1  8/102 (7.84%)  9 9/96 (9.38%)  13 7/94 (7.45%)  13
Lip swelling  1  12/102 (11.76%)  13 14/96 (14.58%)  19 10/94 (10.64%)  13
Mouth ulceration  1  7/102 (6.86%)  7 7/96 (7.29%)  9 0/94 (0.00%)  0
Nausea  1  0/102 (0.00%)  0 8/96 (8.33%)  19 0/94 (0.00%)  0
Oedema mouth  1  0/102 (0.00%)  0 6/96 (6.25%)  11 9/94 (9.57%)  15
Oral pruritus  1  51/102 (50.00%)  95 46/96 (47.92%)  109 33/94 (35.11%)  54
Palatal oedema  1  0/102 (0.00%)  0 7/96 (7.29%)  8 0/94 (0.00%)  0
Paraesthesia oral  1  6/102 (5.88%)  7 0/96 (0.00%)  0 0/94 (0.00%)  0
Swollen tongue  1  0/102 (0.00%)  0 10/96 (10.42%)  13 0/94 (0.00%)  0
Tongue ulceration  1  8/102 (7.84%)  9 0/96 (0.00%)  0 0/94 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pharyngeal oedema  1  0/102 (0.00%)  0 9/96 (9.38%)  12 0/94 (0.00%)  0
Rhinorrhoea  1  7/102 (6.86%)  7 0/96 (0.00%)  0 0/94 (0.00%)  0
Throat irritation  1  54/102 (52.94%)  93 45/96 (46.88%)  99 29/94 (30.85%)  46
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation.
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: NCT02256553    
Other Study ID Numbers: P08607
First Submitted: October 1, 2014
First Posted: October 3, 2014
Results First Submitted: December 7, 2015
Results First Posted: January 18, 2016
Last Update Posted: March 3, 2017