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A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

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ClinicalTrials.gov Identifier: NCT01918033
Recruitment Status : Completed
First Posted : August 7, 2013
Results First Posted : August 15, 2014
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Perennial Allergic Rhinitis
Interventions: Drug: Desloratadine 5 mg
Drug: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Desloratadine 5 mg Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Desloratadine 10 mg Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Placebo Participants receive two placebo tablets orally once daily for up to 2 weeks

Participant Flow:   Overall Study
    Desloratadine 5 mg   Desloratadine 10 mg   Placebo
STARTED   203   203   202 
Treated   202 [1]   203   201 [1] 
COMPLETED   198   201   199 
NOT COMPLETED   5   2   3 
Adverse Event                1                0                2 
Lost to Follow-up                0                1                0 
Protocol Violation                2                0                1 
Withdrawal by Subject                2                1                0 
[1] One randomized participant did not receive study drug.



  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
Desloratadine 5 mg Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
Desloratadine 10 mg Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Placebo Participants receive two placebo tablets orally once daily for up to 2 weeks
Total Total of all reporting groups

Baseline Measures
   Desloratadine 5 mg   Desloratadine 10 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 203   203   202   608 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.3  (13.1)   33.7  (11.9)   34.7  (12.6)   34.2  (12.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      116  57.1%      105  51.7%      121  59.9%      342  56.3% 
Male      87  42.9%      98  48.3%      81  40.1%      266  43.8% 


  Outcome Measures

1.  Primary:   Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2   [ Time Frame: Baseline and Week 2 ]

2.  Primary:   Number of Participants Experiencing an Adverse Event (AE)   [ Time Frame: Up to Week 4 ]

3.  Primary:   Number of Participants Discontinuing Study Drug Due to an AE   [ Time Frame: Up to Week 2 ]

4.  Secondary:   Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1   [ Time Frame: Baseline and Day 3, Week 1 ]

5.  Secondary:   Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]

6.  Secondary:   Change From Baseline in Nasal Finding Score Assessed by the Investigator   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]

7.  Secondary:   Change From Baseline in Eye Symptom Score Assessed by the Investigator   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]

8.  Secondary:   Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator   [ Time Frame: Day 3, Week 1, Week 2 ]

9.  Secondary:   Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]

10.  Secondary:   Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]

11.  Secondary:   Change From Baseline in Eye Symptom Score Reported in Participant Diaries   [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  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

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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01918033     History of Changes
Other Study ID Numbers: 4117-200
132244 ( Registry Identifier: JAPIC-CTI )
First Submitted: August 5, 2013
First Posted: August 7, 2013
Results First Submitted: July 24, 2014
Results First Posted: August 15, 2014
Last Update Posted: April 10, 2017