Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00974571

First received: September 9, 2009

Last updated: May 7, 2010

Last verified: May 2010

History of Changes

Results First Received: September 17, 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:	Perennial Allergic Rhinitis
Interventions:	Drug: montelukast sodium Drug: Comparator: cetirizine 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
74 study sites in the United States Primary Therapy: Nov-2001 to May-2002

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

74 study sites in the United States

Primary Therapy: Nov-2001 to May-2002

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 rhinitis symptoms score during the run-in period were excluded from randomization.

Reporting Groups

	Description
Montelukast 10 mg	Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
Cetirizine 10 mg	Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
Placebo	Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.

Participant Flow: Overall Study

	Montelukast 10 mg	Cetirizine 10 mg	Placebo
STARTED	630	122	613
COMPLETED	562	106	530
NOT COMPLETED	68	16	83
Adverse Event	31	4	27
Lack of Efficacy	3	2	9
Lost to Follow-up	2	1	2
Protocol Violation	13	4	18
Withdrawal by Subject	14	5	16
Patient Moved	1	0	1
Unspecified	4	0	10

Baseline Characteristics

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Outcome Measures

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1. Primary:

Mean Change From Baseline in Daytime Nasal Symptoms Score [ Time Frame: Baseline and first 4 weeks of a 6-week treatment period ]

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2. Secondary:

Mean Change From Baseline in Nighttime Symptoms Score [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]

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3. Secondary:

Mean Change From Baseline in Composite Symptoms Score [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]

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4. Secondary:

Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: End of the first 4 weeks in 6-week treatment period ]

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5. Secondary:

Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: End of the first 4 weeks in 6-week treatment period ]

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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
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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:	NCT00974571 History of Changes
Other Study ID Numbers:	2009_659, MK0476-246
Study First Received:	September 9, 2009
Results First Received:	September 17, 2009
Last Updated:	May 7, 2010
Health Authority:	United States: Food and Drug Administration

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