Uncomplicated Pelvic Inflammatory Disease; Treatment With Moxifloxacin. - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00683865

Purpose

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Condition	Intervention	Phase
Pelvic Inflammatory Disease	Drug: Ofloxacin Drug: Avelox (Moxifloxacin, BAY12-8039)	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Pelvic Inflammatory Disease

Drug Information available for: Metronidazole Metronidazole hydrochloride Ofloxacin Levofloxacin Ofloxacin hydrochloride Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Clinical response 5 to 24 days after the last dose of study medication [ Time Frame: 5 to 24 days after the last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication [ Time Frame: visit 28 to 42 days after last dose ] [ Designated as safety issue: No ]
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose [ Time Frame: (Day 4-7) and at follow-up 28 to 42 days after last dose ] [ Designated as safety issue: No ]
Reduction from baseline in pain report at the different assessment visits [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]
Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [ Time Frame: Over the entire trial period (overall) ] [ Designated as safety issue: No ]

Enrollment:	632
Study Start Date:	April 2003
Study Completion Date:	October 2004

Arms	Assigned Interventions
Active Comparator: Arm 1	Drug: Ofloxacin Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Experimental: Arm 2	Drug: Avelox (Moxifloxacin, BAY12-8039) Moxifloxacin 400 mg po od for 14 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683865

Show 77 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00683865 History of Changes
Other Study ID Numbers:	10995
Study First Received:	May 21, 2008
Last Updated:	June 19, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices United Kingdom: Medicines and Healthcare Products Regulatory Agency Denmark: Ethics Committee Finland: Ethics Committee France: Ministry of Health Greece: Ethics Committee Hungary: National Institute of Pharmacy Italy: Ministry of Health Lithuania: State Medicine Control Agency - Ministry of Health Poland: Ministry of Health Sweden: Regional Ethical Review Board South Africa: National Health Research Ethics Council Russia: Ethics Committee

Keywords provided by Bayer:

Antibiotic treatment
Pelvic infection
Interventional study
Female

Additional relevant MeSH terms:

Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female
Metronidazole
Moxifloxacin
Ofloxacin
Norgestimate, ethinyl estradiol drug combination
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses

Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 24, 2012