A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00960141
First received: August 14, 2009
Last updated: February 27, 2014
Last verified: February 2014
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: montelukast sodium
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

Twenty-nine study centers in the United States.

Therapy Period: August 2000 to October 2000


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 Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
Montelukast Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.

Participant Flow:   Overall Study
    Placebo     Montelukast     Loratadine  
STARTED     333     326     170  
COMPLETED     323     309     163  
NOT COMPLETED     10     17     7  
Adverse Event                 4                 8                 2  
Lack of Efficacy                 3                 4                 2  
Lost to Follow-up                 1                 0                 0  
Protocol Violation                 1                 3                 2  
Withdrawal by Subject                 1                 2                 1  



  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.
No text entered.

Reporting Groups
  Description
Placebo Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
Montelukast Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Loratadine Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Montelukast     Loratadine     Total  
Number of Participants  
[units: participants]
  333     326     170     829  
Age  
[units: years]
Mean ( Full Range )
  36.4  
  ( 15 to 82 )  
  36.3  
  ( 15 to 75 )  
  37.5  
  ( 15 to 66 )  
  36.6  
  ( 15 to 82 )  
Gender  
[units: participants]
       
Female     222     227     119     568  
Male     111     99     51     261  
Daytime Eye Symptoms score [1]
[units: Units on a Scale]
Mean ± Standard Deviation
  1.46  ± 0.78     1.46  ± 0.76     1.44  ± 0.80     1.46  ± 0.77  
Daytime Nasal Symptoms Score [2]
[units: Units on a Scale]
Mean ± Standard Deviation
  2.09  ± 0.44     2.14  ± 0.43     2.08  ± 0.40     2.11  ± 0.43  
Nighttime Symptoms Score [3]
[units: Units on a Scale]
Mean ± Standard Deviation
  1.53  ± 0.62     1.49  ± 0.60     1.54  ± 0.68     1.52  ± 0.62  
Rhinoconjunctivitis Quality-of-Life score [4]
[units: Units on a Scale]
Mean ± Standard Deviation
  3.18  ± 1.00     3.20  ± 1.00     3.26  ± 1.08     3.20  ± 1.02  
[1] Patients were asked to rate each eye symptom (tearing, itchy, red, and puffy eyes) daily in the evening on a 4-point scale [0(best) to 3(worst)]. The Daytime Eye Symptoms score is the average of these 4 symptoms. Baseline is computed as average of daily values during the prerandomization run-in period.
[2] Patients were asked to rate each of 4 nasal symptoms (Congestion, Rhinorrhea, Itching, and Sneezing) daily in the evening on a 4-point scale [0(best) to 3(worst)]. The Daytime Nasal Symptoms Score is the average of these 4 symptoms . Baseline is computed as average of daily values during the prerandomization run-in period (includes the 3 to 5 days prior to Visit 3).
[3] Patients were asked to rate each symptom (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) daily in the morning on a 4-point scale [0(best) to 3(worst)]. The Nighttime Symptoms Score is the average of these 3 symptoms. Baseline is computed as average of daily values during the prerandomization run-in period.
[4] Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life Questionnaire Scored [0(best) to 3(worst)].



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

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

3.  Secondary:   Mean Change From Baseline in Daytime Eye Symptoms Score   [ Time Frame: Baseline and Week 2 ]

4.  Secondary:   Patient's Global Evaluation of Allergic Rhinitis   [ Time Frame: Week 2 (or upon discontinuation) ]

5.  Secondary:   Physician's Global Evaluation of Allergic Rhinitis   [ Time Frame: Week 2 ]

6.  Secondary:   Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score   [ Time Frame: Baseline and Week 2 ]


  Serious Adverse Events


  Other Adverse Events


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00960141     History of Changes
Other Study ID Numbers: 0476-192, MK0476-192, 2009_633
Study First Received: August 14, 2009
Results First Received: August 31, 2009
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration