Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis

This study has been terminated.

( The study was prematurely terminated due to slow enrollment beyond the planned study timelines. )

Study NCT00493038 Information provided by Bayer

First Received on June 26, 2007. Last Updated on November 25, 2011 History of Changes

Results First Received: January 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Conditions:	Sinusitis Bacterial Infections
Interventions:	Drug: Moxifloxacin (Avelox, BAY12-8039) Drug: Amoxicillin/Clavulanate

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
Enrollment started on 13 Feb 2006 and the last study visit occurred on 20 Jan 2008. The study was conducted at 34 active otorhinolaryngology centers in Italy.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of patients screened: 293 Number of patients having at least one observation under study medication: 287 (intention-to-treat population = ITT population) Number of patients adhered to major predefined aspects of the study protocol: 251 (per-protocol population = PP population). Primary population for efficacy was PP.

Reporting Groups

	Description
Moxifloxacin (Avelox, BAY12-8039)	Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
Amoxicillin/Clavulanate	Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days

Participant Flow for 2 periods

Period 1: Treatment

	Moxifloxacin (Avelox, BAY12-8039)	Amoxicillin/Clavulanate
STARTED	147	146
Randomization	147	146
Treated With Study Medication	145	142
Test-of-Cure Visit	123	126
COMPLETED	123	126
NOT COMPLETED	24	20
Adverse Event	8	4
Lost to Follow-up	5	3
Withdrawal by Subject	11	12
unknown	0	1

Period 2: Follow-up

	Moxifloxacin (Avelox, BAY12-8039)	Amoxicillin/Clavulanate
STARTED	123	126
COMPLETED	122	126
NOT COMPLETED	1	0
Lost to Follow-up	1	0

Baseline Characteristics

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Reporting Groups

	Description
Moxifloxacin (Avelox, BAY12-8039)	Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
Amoxicillin/Clavulanate	Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days

Baseline Measures

	Moxifloxacin (Avelox, BAY12-8039)	Amoxicillin/Clavulanate	Total
Number of Participants [units: participants]	145	142	287
Age [units: years] Mean ± Standard Deviation	41.7 ± 13.2	39.7 ± 13.6	40.7 ± 13.4
Age, Customized [units: participants]
<=18 years	0	0	0
>18 and <65 years	133	132	265
>=65 years	12	10	22
Gender [units: participants]
Female	63	75	138
Male	82	67	149

Outcome Measures

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1. Primary:

Number of Participants With Response (Per-protocol Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]

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2. Secondary:

Number of Participants With Response (Intent-to-treat Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]

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3. Secondary:

Number of Participants With Response (Per-protocol Population) [ Time Frame: End of Follow-up, Day 24-30 after treatment ]

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4. Secondary:

Number of Participants With Response (Microbiologically Valid Patients) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]

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5. Secondary:

Number of Participants With Response (Microbiologically Valid Patients) [ Time Frame: End of Follow-up, Day 24-30 after treatment ]

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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 results of the trial as well as any discoveries and inventions, are exclusive property of the Promoter.

Publications on scientific review, comments or presentations about the study in scientific environment must be agreed between the Sponsor and the investigator who engages to submit to Bayer, any publication by sending one text or presentations at least 60 days before the expected publication for comments and corrections.

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 prematurely terminated due to slow enrollment beyond the planned study timelines.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer S.p.A.
ClinicalTrials.gov Identifier:	NCT00493038 History of Changes
Other Study ID Numbers:	11881, 2005-002779-34
Study First Received:	June 26, 2007
Results First Received:	January 20, 2009
Last Updated:	November 25, 2011
Health Authority:	Italy: Ministry of Health