BAY12-8039: 5 Days for Sinusitis vs Placebo

This study has been completed.

Study NCT00492024 Information provided by Bayer

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

Results First Received: March 19, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Sinusitis
Interventions:	Drug: Moxifloxacin (Avelox, BAY12-8039) 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
The study was conducted at 37 investigative centers in the United States from January 2005 to March 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Modified Intent-to-Treat (MITT): Subjects who received at least 1 dose of study drug with a baseline sinus culture positive for at least 1 of 5 common bacteria that cause sinusitis (73 moxifloxacin [M], 45 placebo [P]). Per protocol (PP): Subjects with a positive baseline culture (as above) meeting a long list of additional criteria (62 M, 42 P).

Reporting Groups

	Description
Moxifloxacin 400 mg	Moxifloxacin 400mg once daily for 5 days
Placebo	Matching placebo for 5 days

Participant Flow for 2 periods

Period 1: Treatment

	Moxifloxacin 400 mg	Placebo
STARTED	251	123
COMPLETED	222	101
NOT COMPLETED	29	22
Adverse Event	3	1
Lack of Efficacy	21	20
Lost to Follow-up	3	1
Withdrawal by Subject	2	0

Period 2: Follow up

	Moxifloxacin 400 mg	Placebo
STARTED	222	101
COMPLETED	221	99
NOT COMPLETED	1	2
Lack of Efficacy	0	1
Lost to Follow-up	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Moxifloxacin 400 mg	Moxifloxacin 400mg once daily for 5 days
Placebo	Matching placebo for 5 days

Baseline Measures

	Moxifloxacin 400 mg	Placebo	Total
Number of Participants [units: participants]	251	123	374
Age [units: years] Mean ± Standard Deviation	40.1 ± 13.8	40.3 ± 13.0	40.2 ± 13.5
Gender [units: participants]
Female	165	80	245
Male	86	43	129
Causative Organisms Isolated from Pretreatment Specimens at Study Entry ^[1] [units: participants]
Streptococcus pneumoniae	32	13	45
Moraxella catarrhalis	7	12	19
Haemophilus influenzae	28	15	43
Streptococcus pyogenes	2	2	4
Staphylococcus aureus	11	5	16
Non causative pathogene	66	32	98
No pathogene growth	109	45	154
Location of infection ^[2] [units: participants]
Left	82	37	119
Right	94	46	140
Bilateral	75	40	115
Severity of infection ^[3] [units: participants]
Moderate	153	72	225
Severe	90	49	139
Mild	8	2	10
Duration of infection ^[4] [units: days] Mean ± Standard Deviation
Mean±Standard Deviation	13.2 ± 5.4	12.7 ± 4.7	13.0 ± 5.1

[1]	Causative organisms identified by pre-therapy sinus puncture (more than one organism was identified for some patients)
[2]	Location of sinus infection, left, right, or bilateral
[3]	Severity of infection as asessed by the investigator
[4]	Subgroup analyses were performed on subjects with differing durations of infection of 7 to 14 days, 15 to 21 days, and 22 to 27 days.

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Subjects With Clinical Cure (Modified Intent-to-Treat (MITT)) [ Time Frame: At 'Test-of-Cure' (TOC), Day 1-5 after end of treatment ]

Show Outcome Measure 1

2. Secondary:

Treatment Day When Patients Reached Symptom Improvement as Measured by Patient Reported Data, Using Last Observation Carried Forward (LOCF) Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ]

Show Outcome Measure 2

3. Secondary:

Treatment Day When Patients Returned to Normal Activities as Measured by Patient Reported Data, Using LOCF Approach [ Time Frame: Daily until 'Test-Of-Cure' (Day 1-5 after end of treatment) ]

Show Outcome Measure 3

4. Secondary:

Percentage of Subjects With Clinical Improvement During Therapy [ Time Frame: Day 3 of treatment ]

Show Outcome Measure 4

5. Secondary:

Percentage of Subjects With Continued Clinical Cure During Long-Term Follow-Up [ Time Frame: Day 12 to 26 after end of treatment ]

Show Outcome Measure 5

6. Other Pre-specified:

Percentage of Subjects With Clinical Cure (Per Protocol Population (PP)) [ Time Frame: At 'Test-of-Cure', Day 1-5 after end of treatment ]

Show Outcome Measure 6

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
Confounding factors include concomitant medication for symptomatic relief not standardised, TOC visit occured earlier than for other sinusitis studies, response on placebo underestimated and short-term relief provided by the sinus tap.

Results Point of Contact:

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

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00492024 History of Changes
Other Study ID Numbers:	11566
Study First Received:	June 26, 2007
Results First Received:	March 19, 2009
Last Updated:	March 25, 2011
Health Authority:	United States: Food and Drug Administration