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Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00963599
First received: August 19, 2009
Last updated: June 21, 2010
Last verified: June 2010
History of Changes
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: Comparator: montelukast/loratadine
Drug: Comparator: montelukast
Drug: Comparator: loratadine
Drug: Comparator: placebo

  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

Forty study centers in the United States.

Therapy Period: September 1999 to November 1999

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who required excluded medication and those who did not meet a minimum predefined level of combined Daytime Nasal Symptoms score during the run-in period were excluded from randomization.

Reporting Groups
  Description
Placebo Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Loratadine Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast/Loratadine Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks

Participant Flow:   Overall Study
    Placebo     Montelukast     Loratadine     Montelukast/Loratadine  
STARTED     149     155     301     302  
COMPLETED     143     149     292     288  
NOT COMPLETED     6     6     9     14  
Adverse Event                 2                 0                 1                 2  
Lack of Efficacy                 0                 2                 1                 4  
Lost to Follow-up                 0                 1                 1                 1  
Protocol Violation                 2                 2                 3                 4  
Withdrawal by Subject                 2                 1                 3                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Loratadine Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast/Loratadine Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     Montelukast     Loratadine     Montelukast/Loratadine     Total  
Number of Participants  
[units: participants]
 		  149     155     301     302     907  
Age  
[units: Years]
Mean ( Full Range ) 		  36.9  
  ( 15 to 81 )   		  35.2  
  ( 15 to 65 )   		  37.1  
  ( 15 to 82 )   		  37.6  
  ( 15 to 78 )   		  36.9  
  ( 15 to 82 )  
Gender  
[units: participants]
 		         
Female     86     102     191     208     587  
Male     63     53     110     94     320  
Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.71  ± 0.45     1.82  ± 0.43     1.82  ± 0.45     1.78  ± 0.46     1.79  ± 0.45  
Daytime Congestion score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  2.26  ± 0.56     2.31  ± 0.50     2.37  ± 0.52     2.31  ± 0.58     2.32  ± 0.54  
Daytime Eye Symptoms Score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.31  ± 0.73     1.38  ± 0.73     1.38  ± 0.78     1.38  ± 0.77     1.37  ± 0.76  
Daytime Nasal Itching score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.94  ± 0.67     1.94  ± 0.70     1.93  ± 0.79     1.89  ± 0.73     1.92  ± 0.74  
Daytime Nasal Symptoms Score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  2.01  ± 0.44     2.06  ± 0.39     2.09  ± 0.44     2.01  ± 0.43     2.04  ± 0.43  
Daytime Rhinorrhea score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  2.02  ± 0.70     2.05  ± 0.61     2.16  ± 0.58     1.98  ± 0.66     2.06  ± 0.64  
Daytime Sneezing score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.81  ± 0.74     1.93  ± 0.65     1.89  ± 0.74     1.87  ± 0.68     1.87  ± 0.71  
Nasal Congestion Upon Awakening [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  2.17  ± 0.65     2.25  ± 0.56     2.26  ± 0.61     2.20  ± 0.63     2.23  ± 0.62  
Nighttime Symptoms Score [1]
[units: Units on a Scale]
Mean ± Standard Deviation 		  1.32  ± 0.65     1.50  ± 0.64     1.47  ± 0.63     1.46  ± 0.66     1.45  ± 0.65  
Rhinoconjunctivitis Quality-of-Life Score [2]
[units: Units on a Scale]
Mean ± Standard Deviation 		  3.06  ± 1.09     3.14  ± 0.98     3.10  ± 1.02     3.25  ± 1.08     3.15  ± 1.05  
[1] 0 (best) to 3 (worst) point scale
[2] 0 (best) to 6 (worst) point scale



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Daytime Nasal Symptoms Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in Nighttime Symptoms Score   [ Time Frame: Baseline and Week 2 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Mean Change From Baseline in Nighttime Symptoms Score
Measure Description Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Time Frame Baseline and Week 2  
Safety Issue No  

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.
The primary efficacy analyses were based on the intention-to-treat (all-patients-treated) principle, i.e., all patients who had a baseline and at least one posttreatment measurement were included.

Reporting Groups
  Description
Placebo Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Loratadine Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
Montelukast/Loratadine Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks

Measured Values
    Placebo     Montelukast     Loratadine     Montelukast/Loratadine  
Number of Participants Analyzed  
[units: participants]
 		  148     151     300     299  
Mean Change From Baseline in Nighttime Symptoms Score  
[units: Units on a Scale]
Least Squares Mean ( 95% Confidence Interval ) 		  -0.12  
  ( -0.20 to -0.04 )   		  -0.29  
  ( -0.37 to -0.22 )   		  -0.26  
  ( -0.31 to -0.20 )   		  -0.28  
  ( -0.34 to -0.23 )  

No statistical analysis provided for Mean Change From Baseline in Nighttime Symptoms Score



3.  Secondary:   Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms)   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in Daytime Eye Symptoms Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in Daytime Nasal Congestion Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline in Daytime Rhinorrhea Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in Daytime Nasal Itching Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in Daytime Sneezing Score   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in Nasal Congestion Upon Awakening   [ Time Frame: Baseline and Week 2 ]
  Show Outcome Measure 9

10.  Secondary:   Patient's Global Evaluation of Allergic Rhinitis   [ Time Frame: Week 2 ]
  Show Outcome Measure 10

11.  Secondary:   Physician's Global Evaluation of Allergic Rhinitis   [ Time Frame: Week 2 ]
  Show Outcome Measure 11

12.  Secondary:   Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score   [ Time Frame: Week 2 ]
  Show Outcome Measure 12


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00963599     History of Changes
Other Study ID Numbers: 2009_645, MK0476A-117
Study First Received: August 19, 2009
Results First Received: August 31, 2009
Last Updated: June 21, 2010
Health Authority: United States: Food and Drug Administration