Pelvic Inflammatory DiseasePhase 3NCT00453349
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) and Levofloxacin & Metronidazole in people with Pelvic Inflammatory Disease, run by Bayer at 13 sites in 7 countries.
Trial summary
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039) and Levofloxacin & Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Jan 2007to May 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.
Who cannot join
- Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
China6 sites
Study site
Beijing, 100034
Study site
Beijing, 100083
Study site
Chengdu, Sichuan, 610041
Study site
Chongqing, 400010
Study site
Shanghai, 200011
Study site
Shenyang, Liaoning, 110004
About this 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 (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Moxifloxacin (Avelox, BAY12-8039), Levofloxacin & Metronidazole
- Keywords
- Uncomplicated pelvic inflammatory disease
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin & MetronidazoleDrug
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
| Levofloxacin plus Metronidazole | Active comparator | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days Receives: Drug: Levofloxacin & Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.
Measured: 7 - 14 days after completion of study drug therapy
Secondary outcomes (10)
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".
Measured: 7 - 14 days after completion of study drug therapy
Clinical Response on Treatment for Per Protocol Population
At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).
Measured: 4 - 7 days after start of therapy
Clinical Response on Treatment for Intent To Treat Population
Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.
Measured: 4 - 7 days after start of therapy
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.
Measured: 7 - 14 days at TOC visit
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.
Measured: 7 - 14 days at TOC visit
Clinical Response at Follow-up Visit on Per Protocol Population
Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.
Measured: 28 - 42 days after completion of study drug therapy
Clinical Response at Follow-up Visit on Intent To Treat Population
All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.
Measured: 28 - 42 days after completion of study drug therapy
Bacteriological Response at Follow-up Visit Microbiologically Valid
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Measured: 28 - 42 days after completion of study drug therapy
Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Measured: 28 - 42 days after completion of study drug therapy
Number of Subjects Who Received Alternative Medicine
As alternative medicine any systemic antibacterial medication was considered.
Measured: Up to 42 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453349
- Sponsor's protocol ID
- 11981
- Other IDs
- 2006-000874-56
- Status last verified
- Sep 2014
- First submitted
- 27 Mar 2007
- Last updated
- 8 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20716255
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00453349
- Acronym / sponsor ID
- 11981
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- Uncomplicated pelvic inflammatory disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Posted 30 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin | Experimental | Drug: Moxifloxacin (Avelox, BAY12-8039)Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days |
| Levofloxacin plus Metronidazole | Active comparator | Drug: Levofloxacin & MetronidazoleLevofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.
Key exclusion criteria (1 listed)
- Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039)Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | Drug | Moxifloxacin |
| Levofloxacin & MetronidazoleLevofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days | Drug | Levofloxacin plus Metronidazole |
Primary outcome
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Time frame: 7 - 14 days after completion of study drug therapy
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.
10 secondary outcomes
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
Time frame: 7 - 14 days after completion of study drug therapy
Clinical Response on Treatment for Per Protocol Population
Time frame: 4 - 7 days after start of therapy
Clinical Response on Treatment for Intent To Treat Population
Time frame: 4 - 7 days after start of therapy
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
Time frame: 7 - 14 days at TOC visit
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
Time frame: 7 - 14 days at TOC visit
Clinical Response at Follow-up Visit on Per Protocol Population
Time frame: 28 - 42 days after completion of study drug therapy
Clinical Response at Follow-up Visit on Intent To Treat Population
Time frame: 28 - 42 days after completion of study drug therapy
Bacteriological Response at Follow-up Visit Microbiologically Valid
Time frame: 28 - 42 days after completion of study drug therapy
Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
Time frame: 28 - 42 days after completion of study drug therapy
Number of Subjects Who Received Alternative Medicine
Time frame: Up to 42 days after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20716255Judlin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxifloxacin (Avelox, BAY12-8039) and Levofloxacin & Metronidazole in people with Pelvic Inflammatory Disease, run by Bayer at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China, Taiwan, Indonesia, Pakistan, Philippines and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population (time frame: 7 - 14 days after completion of study drug therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.