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

NCT ID: NCT00453349

Last Updated: 2014-09-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)

Detailed Description

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Conditions

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Pelvic Inflammatory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Moxifloxacin

Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days

Group Type EXPERIMENTAL

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type DRUG

Moxifloxacin (Avelox, BAY12-8039) 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

Group Type ACTIVE_COMPARATOR

Levofloxacin & Metronidazole

Intervention Type DRUG

Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Interventions

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Moxifloxacin (Avelox, BAY12-8039)

Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days

Intervention Type DRUG

Levofloxacin & Metronidazole

Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.

Exclusion Criteria

* Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Shenyang, Liaoning, China

Site Status

Chengdu, Sichuan, China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Chongqing, , China

Site Status

Shanghai, , China

Site Status

Jakarta, , Indonesia

Site Status

Karachi, , Pakistan

Site Status

Manila, , Philippines

Site Status

Seoul, , South Korea

Site Status

Taipei, Taiwan, Taiwan

Site Status

Taizung, , Taiwan

Site Status

Bangkok, Bangkok, Thailand

Site Status

Countries

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China Indonesia Pakistan Philippines South Korea Taiwan Thailand

References

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Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.

Reference Type RESULT
PMID: 20716255 (View on PubMed)

Other Identifiers

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2006-000874-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

11981

Identifier Type: -

Identifier Source: org_study_id

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