Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)(COMPLETED)

This study has been completed.

Study NCT00552110 Information provided by Schering-Plough

First Received on October 30, 2007. Last Updated on October 22, 2010 History of Changes

Results First Received: May 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Treatment
Condition:	Seasonal Allergic Rhinitis
Interventions:	Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) Drug: mometasone furoate nasal spray (MFNS) once daily Drug: oxymetazoline nasal spray (OXY) twice daily Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Combination1	Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
Combination3	MFNS with OXY 3 sprays once daily
Mometasone	MFNS once daily
Oxymetazoline	OXY twice daily
Placebo	Placebo nasal spray

Participant Flow: Overall Study

	Combination1	Combination3	Mometasone	Oxymetazoline	Placebo
STARTED	146 ^[1]	139	139	141 ^[1]	142
COMPLETED	142	134	137	133	133
NOT COMPLETED	4	5	2	8	9
Serious or Life-Threatening AE	0	0	1	0	0
Lack of Efficacy	1	0	0	1	4
Withdrawal by Subject	0	2	0	3	2
Lost to Follow-up	0	0	0	1	1
Failed to Comply With Study Requirements	1	1	1	0	1
Withdrawn per Sponsor	0	1	0	0	1
Use of Prohibited Medication	1	1	0	0	0
Delay of Study due to Relabeling	0	0	0	1	0
Increased Blood Pressure at Visit 2	0	0	0	1	0
Nonserious Adverse Event (AE)	1	0	0	1	0

[1]	One subject was excluded from the intent to treat population because there was no record of dosing.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Combination1	Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
Combination3	MFNS with OXY 3 sprays once daily
Mometasone	MFNS once daily
Oxymetazoline	OXY twice daily
Placebo	Placebo nasal spray

Baseline Measures

	Combination1	Combination3	Mometasone	Oxymetazoline	Placebo	Total
Number of Participants [units: participants]	145	139	139	140	142	705
Age ^[1] [units: participants]
<=18 years	8	12	5	5	12	42
Between 18 and 65 years	135	124	132	131	127	649
>=65 years	2	3	2	4	3	14
Gender ^[1] [units: participants]
Female	93	93	101	95	89	471
Male	52	46	38	45	53	234

[1]	Intention to treat population: all randomized subjects who had taken at least one dose of study drug

Outcome Measures

Show All Outcome Measures

1. Primary:

Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 [ Time Frame: 15 days of treatment ]

Show Outcome Measure 1

2. Primary:

Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score [ Time Frame: from baseline to hour 4 on Day 1 ]

Show Outcome Measure 2

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

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
Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00552110 History of Changes
Other Study ID Numbers:	P04500
Study First Received:	October 30, 2007
Results First Received:	May 15, 2009
Last Updated:	October 22, 2010
Health Authority:	United States: Food and Drug Administration