This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01644617
First received: July 17, 2012
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: December 20, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-8237 12 Development Units (DU) 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.
MK-8237 6 DU Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Placebo Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.

Participant Flow:   Overall Study
    MK-8237 12 Development Units (DU)   MK-8237 6 DU   Placebo
STARTED   42   41   41 
COMPLETED   36   36   34 
NOT COMPLETED   6   5   7 
Withdrawal by Subject                3                4                1 
Lost to Follow-up                0                1                0 
Adverse Event                3                0                6 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
MK-8237 12 Development Units (DU) 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.
MK-8237 6 DU Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Placebo Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
Total Total of all reporting groups

Baseline Measures
   MK-8237 12 Development Units (DU)   MK-8237 6 DU   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   41   41   124 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.5  (9.2)   26.7  (7.0)   26.6  (6.1)   26.9  (7.5) 
Sex: Female, Male 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Average TNSS During EEC Challenge Session at Week 16   [ Time Frame: Week 16 ]

3.  Secondary:   Average TNSS During EEC Challenge Session at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16   [ Time Frame: Week 16 ]

6.  Secondary:   Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8   [ Time Frame: Week 8 ]

7.  Secondary:   Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24   [ Time Frame: Week 24 ]

8.  Secondary:   Average TOSS During EEC Challenge Session at Week 16   [ Time Frame: Week 16 ]

9.  Secondary:   Average TOSS During EEC Challenge Session at Week 8   [ Time Frame: Week 8 ]

10.  Secondary:   HDM-specific Immunoglobulin E (IgE) Levels at Week 8   [ Time Frame: Week 8 ]

11.  Secondary:   HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8   [ Time Frame: Week 8 ]

12.  Secondary:   Change From Baseline in HDM-specific IgE Levels at Week 8   [ Time Frame: Baseline and Week 8 ]

13.  Secondary:   Change From Baseline in HDM-specific IgG4 Levels at Week 8   [ Time Frame: Time Frame: Baseline and Week 8 ]

14.  Secondary:   Percentage of Participants Who Experienced At Least One Adverse Event (AE)   [ Time Frame: From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks) ]

15.  Secondary:   Percentage of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: From first dose to last dose of treatment (Up to 24 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01644617     History of Changes
Other Study ID Numbers: P07627
2012-001855-38 ( EudraCT Number )
8237-003 ( Other Identifier: Merck Registration Number )
Study First Received: July 17, 2012
Results First Received: December 20, 2016
Last Updated: February 21, 2017