DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

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: Moxifloxacin (Avelox, BAY12-8039) (Drug); Levofloxacin & Metronidazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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

Summary

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

Clinical Details

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 (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)

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 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population

Secondary outcome:

Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population

Clinical Response on Treatment for Per Protocol Population

Clinical Response on Treatment for Intent To Treat Population

Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid

Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism

Clinical Response at Follow-up Visit on Per Protocol Population

Clinical Response at Follow-up Visit on Intent To Treat Population

Bacteriological Response at Follow-up Visit Microbiologically Valid

Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism

Number of Subjects Who Received Alternative Medicine

Eligibility

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

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.

Locations and Contacts

Beijing 100034, China

Beijing 100083, China

Chongqing 400010, China

Shanghai 200011, China

Jakarta, Indonesia

Seoul 133792, Korea, Republic of

Karachi, Pakistan

Manila, Philippines

Taipei 10002, Taiwan

Taizung 402, Taiwan

Bangkok 10700, Thailand

Shenyang, Liaoning 110004, China

Chengdu, Sichuan 610041, China

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: January 2007
Last updated: September 2, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017