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Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01700192
First received: October 2, 2012
Last updated: April 24, 2017
Last verified: April 2017
Results First Received: January 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Conditions: Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Interventions: Biological: MK-8237 tablets
Biological: Placebo tablets
Drug: Rescue Medication: Self-Injectable Epinephrine
Drug: Rescue Medication: Loratadine tablets
Drug: Rescue Medication: Olopatadine ophthalmic drops
Drug: Rescue Medication: Mometasone furoate nasal spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MK-8237 Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
Placebo Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.

Participant Flow:   Overall Study
    MK-8237   Placebo
STARTED   741   741 
Treated   740   741 
All Participants as Treated (APaT)   743 [1]   738 [1] 
COMPLETED   561   613 
NOT COMPLETED   180   128 
Adverse Event                73                18 
Lack of Efficacy                1                0 
Lost to Follow-up                42                29 
Noncompliance with study drug                0                5 
Physician Decision                2                3 
Pregnancy                1                4 
Progressive disease                1                0 
Protocol Violation                3                4 
Technical problems                0                1 
Withdrawal by Subject                56                64 
Never received study drug                1                0 
[1] Three participants randomized to receive placebo were given MK-8237 12 DU.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characteristics refer to all randomized participants.

Reporting Groups
  Description
MK-8237 Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
Placebo Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
Total Total of all reporting groups

Baseline Measures
   MK-8237   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 741   741   1482 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.9  (13.82)   35.2  (13.74)   35.1  (13.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      445  60.1%      430  58.0%      875  59.0% 
Male      296  39.9%      311  42.0%      607  41.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment   [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]

2.  Primary:   Number of Participants Who Experience At Least One Adverse Event (AE)   [ Time Frame: Up to 54 weeks ]

3.  Primary:   Number of Participants Who Discontinue Study Drug Due to an AE   [ Time Frame: Up to 52 weeks ]

4.  Secondary:   Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment   [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]

5.  Secondary:   Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment   [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]

6.  Secondary:   Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment   [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]

7.  Secondary:   Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment   [ Time Frame: Last 8 weeks of treatment (Weeks 44 to 52) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Corporate Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01700192     History of Changes
Other Study ID Numbers: P05607
MK-8237-001 ( Other Identifier: Merck Protocol ID )
Study First Received: October 2, 2012
Results First Received: January 11, 2017
Last Updated: April 24, 2017