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Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pelvic Inflammatory Disease

Intervention: Ofloxacin (Drug); Avelox (Moxifloxacin, BAY12-8039) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Clinical Details

Official title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical response 5 to 24 days after the last dose of study medication

Secondary outcome:

Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication

Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose

Reduction from baseline in pain report at the different assessment visits

Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Hvidovre 2650, Denmark

Odense C DK-5000, Denmark

Roskilde DK-4000, Denmark

Helsinki 00029, Finland

Hämeenlinna 13530, Finland

Joensuu 80210, Finland

Kotka 48210, Finland

Antony Cedex 92166, France

Beaumont 63110, France

Bordeaux 33000, France

Brive-la-gaillarde 19100, France

Cenon 33150, France

Colombes Cedex 92701, France

Creteil Cedex 94010, France

Domont 95330, France

Lille 59037, France

Montauban 82000, France

Montpellier 34059, France

Muret 31600, France

Nancy Cedex 54045, France

Paris 75020, France

Paris 75009, France

Toulouse 31059, France

Berlin 10117, Germany

Berlin 10249, Germany

Budapest 1115, Hungary

Budapest H-1085, Hungary

Eger 3301, Hungary

Györ 9024, Hungary

Kecskemet 6000, Hungary

Pavia 27100, Italy

Perugia 06122, Italy

Trieste 34137, Italy

Klaipeda 92288, Lithuania

Vilnius LT-04130, Lithuania

Vilnius LT-2000, Lithuania

Vilnius LT-2021, Lithuania

Bialystok 15-276, Poland

Krakow 30-501, Poland

Lodz 93-338, Poland

Lublin 20-090, Poland

Owock 05-400, Poland

Poznan 61-701, Poland

Warszawa 00-416, Poland

Warszawa 00-909, Poland

Moscow 117049, Russian Federation

Moscow 117997, Russian Federation

Moscow 107076, Russian Federation

Göteborg 413 45, Sweden

Linköping 581 85, Sweden

Lund 221 85, Sweden

Trollhättan 461 85, Sweden

Varberg 432 81, Sweden

Athens, Attica 115 21, Greece

Athens, Attica 11528, Greece

Bristol, Avon BS2 8HW, United Kingdom

München, Bayern 80336, Germany

Bloemfontein, Free State 9300, South Africa

Johannesburg, Gauteng 2132, South Africa

Johannesburg, Gauteng 1804, South Africa

Pretoria, Gauteng 0001, South Africa

Pretoria, Gauteng, South Africa

London, Greater London WC1E 6AU, United Kingdom

London, Greater London SW17 0QT, United Kingdom

London, Greater London SW10 9NH, United Kingdom

Southampton, Hampshire SO14 0YG, United Kingdom

Dourouti-Ioannina, Ioannina 45500, Greece

Durban, KwaZulu Natal 4001, South Africa

Rostock, Mecklenburg-Vorpommern 18057, Germany

Essen, Nordrhein-Westfalen 45257, Germany

Grevenbroich, Nordrhein-Westfalen 41515, Germany

Leverkusen, Nordrhein-Westfalen 51375, Germany

Wuppertal, Nordrhein-Westfalen 42103, Germany

Nottingham, Nottinghamshire NG5 1PB, United Kingdom

Birmingham, West Midlands B4 6DH, United Kingdom

Cape Town, Western Cape, South Africa

Cape Town, Western Cape 7505, South Africa

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: April 2003
Last updated: October 12, 2014

Page last updated: August 23, 2015

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