A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

This study has been completed.

Study NCT00453349 Information provided by Bayer

First Received on March 27, 2007. Last Updated on November 24, 2010 History of Changes

Results First Received: September 1, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Pelvic Inflammatory Disease
Interventions:	Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin & Metronidazole

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
A total of 463 females with uncomplicated PID were enrolled on the basis of a complete evaluation (interview, medical history and physical examination and laboratory tests). 460 subjects were randomized, 412 completed study treatment (whole medication), and 384 subjects were valid for the primary efficacy analysis.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The efficacy results in ITT are consistent with those in PP, supporting that this is a non-inferiority study and the primary efficacy population was PP not ITT. 76 subjects were excluded from primary efficacy analysis mainly due to essential data missing or invalid, violation of inclusion/exclusion criteria and insufficient duration of therapy.

Reporting Groups

	Description
Moxifloxacin	Moxifloxacin (Avelox, BAY 12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin Plus Metronidazole	Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Participant Flow for 3 periods

Period 1: Randomized

	Moxifloxacin	Levofloxacin Plus Metronidazole
STARTED	228	232
COMPLETED	203 ^[1]	209 ^[2]
NOT COMPLETED	25	23
Adverse Event	12	11
Lack of Efficacy	2	1
Lost to Follow-up	7	5
Protocol Violation	1	1
Withdrawal by Subject	3	5

[1]	203 completed study, 25 were withdrawn from study prematurely
[2]	209 completed study 23 were with withdrawn from study prematurely

Period 2: Reaching of Primary Endpoint (TOC)

	Moxifloxacin	Levofloxacin Plus Metronidazole
STARTED	225 ^[1]	230 ^[2]
Valid for Primary Efficacy Analysis	194	190
COMPLETED	215 ^[3]	219
NOT COMPLETED	10	11
Missing information	10	11

[1]	Subjects who attended the TOC visit or at least had a clinical evaluation at TOC
[2]	i.e. the ITT population
[3]	All PP patients and ITT patients with a clinical response with no missing information

Period 3: Completed Study

	Moxifloxacin	Levofloxacin Plus Metronidazole
STARTED	228	232
Completed Study Treatment	203 ^[1]	209 ^[2]
COMPLETED	201 ^[3]	198 ^[3]
NOT COMPLETED	27	34
Adverse Event	12	11
Lack of Efficacy	2	1
Lost to Follow-up	7	5
Protocol Violation	1	1
Withdrawal by Subject	3	5
Lost to follow up after study treatment	2	11

[1]	25 terminated prematurely
[2]	23 terminated prematurely
[3]	had follow-up assessment or alternative antibiotic assessment

Baseline Characteristics

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Reporting Groups

	Description
Moxifloxacin	Moxifloxacin (Avelox, BAY 12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin Plus Metronidazole	Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Baseline Measures

	Moxifloxacin	Levofloxacin Plus Metronidazole	Total
Number of Participants [units: participants]	228	232	460
Age [units: years] Mean ± Standard Deviation	35.2 ± 8.4	35.4 ± 8.7	35.2 ± 8.6
Gender [units: participants]
Female	228	232	460
Male	0	0	0
Microbiology recovery ^[1] [units: number of participants with pathogenes]	36	36	72
Total pelvic pain score (using modified McCormack score) ^[2] [units: points on a scale] Mean ± Standard Deviation	11.3 ± 3.8	11.6 ± 3.8	11.5 ± 3.8

[1]	Endocervical samples were taken for culture and Polymerase Chain Reaction (PCR) tests within 48 hours prior to start of therapy. The PCR tests were repeated at TOC and Follow-up visits if the pre-therapy results were positive for Neisseria gonorrhoeae and Chlamydia trachomatis.
[2]	Modified McCormack score was used to assess the tenderness at the abdominal and pelvic examination, 0=tenderness absent, 1=tenderness described by the subject but not manifested by facial expression or muscle tone changes, 2=tenderness resulting in altered facial expression or muscle tone, 3=tenderness causing observable marked distress.

Outcome Measures

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1. Primary:

Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population [ Time Frame: 7 - 14 days after completion of study drug therapy ]

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2. Secondary:

Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population [ Time Frame: 7 - 14 days after completion of study drug therapy ]

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3. Secondary:

Clinical Response on Treatment for Per Protocol Population [ Time Frame: 4 - 7 days after start of therapy ]

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4. Secondary:

Clinical Response on Treatment for Intent To Treat Population [ Time Frame: 4 - 7 days after start of therapy ]

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5. Secondary:

Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid [ Time Frame: 7 - 14 days at TOC visit ]

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6. Secondary:

Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism [ Time Frame: 7 - 14 days at TOC visit ]

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7. Secondary:

Clinical Response at Follow up Visit on Per Protocol Population [ Time Frame: 28 - 42 days after completion of study drug therapy ]

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8. Secondary:

Clinical Response at Follow up Visit on Intent To Treat Population [ Time Frame: 28 - 42 days after completion of study drug therapy ]

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9. Secondary:

Bacteriological Response at Follow-up Visit Microbiologically Valid [ Time Frame: 28 - 42 days after completion of study drug therapy ]

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10. Secondary:

Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism [ Time Frame: 28 - 42 days after completion of study drug therapy ]

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11. Secondary:

Number of Subjects Who Received Alternative Medicine [ Time Frame: Up to 42 days after end of 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.

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
Out of the 460 randomized subjects, 5 subjects (3 moxifloxacin subjects, 2 placebo subjects) did not receive any study medication. Only one of these patients had an adverse event (stomachache, randomized to Moxifloxacin).

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 AG
ClinicalTrials.gov Identifier:	NCT00453349 History of Changes
Other Study ID Numbers:	11981, EudraCT 2006-000874-56
Study First Received:	March 27, 2007
Results First Received:	September 1, 2009
Last Updated:	November 24, 2010
Health Authority:	China: State Food and Drug Administration