A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00453349

Purpose

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

Condition	Intervention	Phase
Pelvic Inflammatory Disease	Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin & Metronidazole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Double Dummy, Double Blind, Multi-Center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease. Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Inflammatory Disease

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

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Clinical response 7 to 14 days after the completion of study drug therapy. [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical response on treatment [ Time Frame: 4 to 7 days after start of treatment ] [ Designated as safety issue: Yes ]
Biological response at TOC visit [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]
Clinical response at TOC visit [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]
Clinical and bacteriological responses at follow-up visit [ Time Frame: 28-42 days afterend therapy ] [ Designated as safety issue: Yes ]
Necessity for modifying antibiotic therapy for PID [ Time Frame: from TOC up to end of follow up ] [ Designated as safety issue: Yes ]

Enrollment:	459
Study Start Date:	January 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Avelox (Moxifloxacin, BAY12-8039) Moxifloxacin 400 mg PO once daily for 14 days
Arm 2: Active Comparator	Drug: Levofloxacin & Metronidazole Levofloxacin 500 mg PO once daily for 14 days plus Metronidazole 500 mg twice daily 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453349

Locations

China

Shanghai, China

Beijing, China, 100034

Beijing, China, 100083

Chongqing, China
China, Liaoning

Shenyang, Liaoning, China
China, Sichuan

Chengdu, Sichuan, China, 610041
Indonesia

Jakarta, Indonesia
Korea, Republic of

Seoul, Korea, Republic of, 133792
Pakistan

Karachi, Pakistan
Philippines

Manila, Philippines
Taiwan

Taipei, Taiwan, 100

ask Contact, Taiwan
Thailand

Bangkok, Thailand, 10400

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

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

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No publications provided

Responsible Party:	Therapeutic Area Head ( Bayer HealthCare AG )
Study ID Numbers:	11981, EudraCT 2006-000874-56
Study First Received:	March 27, 2007
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00453349 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Bayer:

Uncomplicated pelvic inflammatory disease

Additional relevant MeSH terms:

Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Physiological Effects of Drugs
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Pelvic Inflammatory Disease
Renal Agents
Infection

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Anti-Bacterial Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Moxifloxacin
Therapeutic Uses
Pelvic Infection
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009