Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

NCT ID: NCT00683865

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

749 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-10-31

Brief Summary

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Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

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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Arm 1

Group Type ACTIVE_COMPARATOR

Ofloxacin

Intervention Type DRUG

Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days

Arm 2

Group Type EXPERIMENTAL

Avelox (Moxifloxacin, BAY12-8039)

Intervention Type DRUG

Moxifloxacin 400 mg po od for 14 days

Interventions

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Ofloxacin

Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days

Intervention Type DRUG

Avelox (Moxifloxacin, BAY12-8039)

Moxifloxacin 400 mg po od for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness;
* Adnexal tenderness on bimanual vaginal examination,
* Temperature \> 38.0°C; - Elevated C-reactive protein value (CRP);
* Signed PIC/IC

Exclusion Criteria

* Pregnancy
* Abnormal lab values
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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Bordeaux, , France

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Brive-la-Gaillarde, , France

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Cenon, , France

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Colombes, , France

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Créteil, , France

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Domont, , France

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Lille, , France

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Montauban, , France

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Montpellier, , France

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Muret, , France

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Nancy, , France

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Paris, , France

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Paris, , France

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Toulouse, , France

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München, Bavaria, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Essen, North Rhine-Westphalia, Germany

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Grevenbroich, North Rhine-Westphalia, Germany

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Leverkusen, North Rhine-Westphalia, Germany

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Wuppertal, North Rhine-Westphalia, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Athens, Attica, Greece

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Athens, Attica, Greece

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Dourouti-Ioannina, Ioannina, Greece

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Budapest, , Hungary

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Budapest, , Hungary

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Eger, , Hungary

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Győr, , Hungary

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Kecskemét, , Hungary

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Pavia, , Italy

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Perugia, , Italy

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Trieste, , Italy

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Bialystok, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Owock, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, KwaZulu-Natal, South Africa

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Cape Town, Western Cape, South Africa

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Cape Town, Western Cape, South Africa

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Gothenburg, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Trollhättan, , Sweden

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Varberg, , Sweden

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Bristol, Avon, United Kingdom

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London, Greater London, United Kingdom

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London, Greater London, United Kingdom

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London, Greater London, United Kingdom

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Southampton, Hampshire, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Hvidovre, , Denmark

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Odense C, , Denmark

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Roskilde, , Denmark

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Joensuu, , Finland

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Kotka, , Finland

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Antony, , France

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Beaumont, , France

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Countries

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Denmark Finland France Germany Greece Hungary Italy Lithuania Poland Russia South Africa Sweden United Kingdom

Other Identifiers

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10995

Identifier Type: -

Identifier Source: org_study_id

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