check_circleStudy Completed

Pelvic Inflammatory Disease

Bayer Identifier:

11981

ClinicalTrials.gov Identifier:

NCT00453349

EudraCT Number:

2006-000874-56

EU CT Number:

Not Available
A Trial Comparing Moxifloxacin versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 Years
  • - Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.
  • - Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.

Trial summary

Enrollment Goal
460
Trial Dates
January 2007 - May 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Obstetrics & Gynecology Hosp. of Fudan Univ.Shanghai, 200011, China
Completed
Peking Univ. First Hosp.Beijing, 100034, China
Completed
Shengjing Hosp. of China Medical Univ.Shenyang, 110004, China
Completed
National Taiwan University HospitalTaipei, 10002, Taiwan
Completed
Chung Shan Medical University HospitalTaizung, 402, Taiwan
Completed
Mahidol UniversityBangkok, 10700, Thailand
Completed
Peking University Third HospitalBeijing, 100083, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China
Completed
2nd Hosp., Chongqing Medical Univ.Chongqing, 400010, China
Completed
Bunda HospitalJakarta, Indonesia
Completed
HanYang University Medical CenterSeoul, 133792, Korea, Republic Of
Completed
Philippine General HospitalManila, Philippines
Completed
Ziauddin Medical University HospitalKarachi, Pakistan

Primary Outcome

  • Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
    date_rangeTime Frame:
    7 - 14 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
    date_rangeTime Frame:
    7 - 14 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No
  • Clinical Response on Treatment for Per Protocol Population
    date_rangeTime Frame:
    4 - 7 days after start of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Clinical Response on Treatment for Intent To Treat Population
    date_rangeTime Frame:
    4 - 7 days after start of therapy
    enhanced_encryption
    Safety Issue:
    No
  • Bacteriological Response at Test Of Cure (TOC) visit microbiologically valid
    date_rangeTime Frame:
    7 – 14 days at TOC visit
    enhanced_encryption
    Safety Issue:
    No
  • Bacteriological Response at Test Of Cure (TOC) visit in Intent To Treat population with causative organism
    date_rangeTime Frame:
    7 – 14 days at TOC visit
    enhanced_encryption
    Safety Issue:
    No
  • Clinical Response at follow-up visit on Per Protocol population
    date_rangeTime Frame:
    28 – 42 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No
  • Clinical Response at follow-up visit on Intent To Treat population
    date_rangeTime Frame:
    28 – 42 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No
  • Bacteriological Response at follow-up visit microbiologically valid
    date_rangeTime Frame:
    28 – 42 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No
  • Bacteriological Response at follow-up visit in Intent To Treat population with causative organism
    date_rangeTime Frame:
    28 – 42 days after completion of study drug therapy
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects who received alternative medicine
    date_rangeTime Frame:
    up to 42 days after end of treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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