The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)

This study has been terminated.

(Based on business priorities. Not related to any safety or efficacy issue & took place before data were unblinded or analyzed)

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00423176

First received: January 17, 2007

Last updated: July 15, 2010

Last verified: July 2010

History of Changes

Results First Received: July 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Sinusitis
Interventions:	Drug: MFNS and antibiotic Drug: Matching Placebo nasal spray plus antibiotic

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)	Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
Placebo	Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).

Participant Flow: Overall Study

	Mometasone Furoate Nasal Spray (MFNS)	Placebo
STARTED	114	123
COMPLETED	98	94
NOT COMPLETED	16	29
Adverse Event	4	6
Treatment Failure	1	6
Lost to Follow-up	4	7
Withdrawal by Subject	4	3
Protocol Violation	1	3
Did not meet protocol eligibility	2	4

Baseline Characteristics

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Reporting Groups

	Description
Mometasone Furoate Nasal Spray (MFNS)	Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
Placebo	Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Total	Total of all reporting groups

Baseline Measures

	Mometasone Furoate Nasal Spray (MFNS)	Placebo	Total
Number of Participants [units: participants]	114	123	237
Age [units: participants]
<=18 years	5	6	11
Between 18 and 65 years	106	107	213
>=65 years	3	10	13
Age [units: years] Mean ± Standard Deviation	39.3 ± 13.2	39.0 ± 14.9	39.2 ± 14.1
Gender [units: participants]
Female	80	72	152
Male	34	51	85

Outcome Measures

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1. Primary:

Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. [ Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period. ]

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2. Primary:

Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline [ Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up 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.

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
The study was terminated early due to a very high screening failure rate (mainly caused by the necessity to demonstrate CT changes at baseline indicative of acute sinusitis), which limits any conclusions.

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:	NCT00423176 History of Changes
Other Study ID Numbers:	P04824
Study First Received:	January 17, 2007
Results First Received:	July 29, 2009
Last Updated:	July 15, 2010
Health Authority:	United States: Food and Drug Administration

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