Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 Mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00453063

First received: March 26, 2007

Last updated: April 1, 2010

Last verified: April 2010

History of Changes

Results First Received: February 3, 2010

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: mometasone furoate Drug: 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Mometasone Furoate Nasal Spray (MFNS)	MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Placebo	Two sprays in each nostril once daily

Participant Flow: Overall Study

	Mometasone Furoate Nasal Spray (MFNS)	Placebo
STARTED	211	215
COMPLETED	208	212
NOT COMPLETED	3	3
Adverse Event	1	2
Withdrawal by Subject	1	1
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Mometasone Furoate Nasal Spray (MFNS)	MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Placebo	Two sprays in each nostril once daily
Total	Total of all reporting groups

Baseline Measures

	Mometasone Furoate Nasal Spray (MFNS)	Placebo	Total
Number of Participants [units: participants]	211	215	426
Age [units: participants]
<=18 years	18	30	48
Between 18 and 65 years	188	181	369
>=65 years	5	4	9
Gender [units: participants]
Female	140	130	270
Male	71	85	156

Outcome Measures

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1. Primary:

Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 [ Time Frame: Baseline and 15 days ]

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2. Primary:

Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 [ Time Frame: Baseline and 15 days ]

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3. Secondary:

Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 [ Time Frame: Baseline and 15 days ]

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4. Secondary:

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) [ Time Frame: Baseline and 15 days ]

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5. Secondary:

Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 [ Time Frame: Baseline and 15 days ]

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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: The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.

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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00453063 History of Changes
Other Study ID Numbers:	P05067
Study First Received:	March 26, 2007
Results First Received:	February 3, 2010
Last Updated:	April 1, 2010
Health Authority:	United States: Food and Drug Administration

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