Clinical trial NCT00453349: A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pelvic Inflammatory Disease
Keywords: Uncomplicated pelvic inflammatory disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-03-28
Enrollment: 460
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
timeFrame: 7 - 14 days after completion of study drug therapy
Secondary outcomes:
measure: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
timeFrame: 7 - 14 days after completion of study drug therapy
measure: Clinical Response on Treatment for Per Protocol Population
timeFrame: 4 - 7 days after start of therapy
measure: Clinical Response on Treatment for Intent To Treat Population
timeFrame: 4 - 7 days after start of therapy
measure: Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
timeFrame: 7 - 14 days at TOC visit
measure: Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
timeFrame: 7 - 14 days at TOC visit
measure: Clinical Response at Follow-up Visit on Per Protocol Population
timeFrame: 28 - 42 days after completion of study drug therapy
measure: Clinical Response at Follow-up Visit on Intent To Treat Population
timeFrame: 28 - 42 days after completion of study drug therapy
measure: Bacteriological Response at Follow-up Visit Microbiologically Valid
timeFrame: 28 - 42 days after completion of study drug therapy
measure: Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
timeFrame: 28 - 42 days after completion of study drug therapy
measure: Number of Subjects Who Received Alternative Medicine
timeFrame: Up to 42 days after end of treatment
Other outcomes:
Locations:
city: Shenyang
country: China
state: Liaoning
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Jakarta
country: Indonesia
city: Seoul
country: Korea, Republic of
city: Karachi
country: Pakistan
city: Manila
country: Philippines
city: Taipei
country: Taiwan
city: Taizung
country: Taiwan
city: Bangkok
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.