A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00960141

First received: August 14, 2009

Last updated: June 9, 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: 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

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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:	NCT00960141 History of Changes
Other Study ID Numbers:	2009_633, MK0476-192
Study First Received:	August 14, 2009
Results First Received:	August 31, 2009
Last Updated:	June 9, 2010
Health Authority:	United States: Food and Drug Administration

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