Trial record 3 of 3 for:
monalisa
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00453349
First received: March 27, 2007
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
| Condition | Intervention | Phase |
|---|---|---|
|
Pelvic Inflammatory Disease |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Levofloxacin & Metronidazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Pelvic Inflammatory Disease
Drug Information available for:
Metronidazole
Metronidazole benzoate
Metronidazole hydrochloride
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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".
- Clinical Response on Treatment for Per Protocol Population [ Time Frame: 4 - 7 days after start of therapy ] [ Designated as safety issue: No ]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).
- Clinical Response on Treatment for Intent To Treat Population [ Time Frame: 4 - 7 days after start of therapy ] [ Designated as safety issue: No ]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.
- Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid [ Time Frame: 7 - 14 days at TOC visit ] [ Designated as safety issue: No ]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.
- Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism [ Time Frame: 7 - 14 days at TOC visit ] [ Designated as safety issue: No ]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.
- Clinical Response at Follow-up Visit on Per Protocol Population [ Time Frame: 28 - 42 days after completion of study drug therapy ] [ Designated as safety issue: No ]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.
- Clinical Response at Follow-up Visit on Intent To Treat Population [ Time Frame: 28 - 42 days after completion of study drug therapy ] [ Designated as safety issue: No ]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.
- Bacteriological Response at Follow-up Visit Microbiologically Valid [ Time Frame: 28 - 42 days after completion of study drug therapy ] [ Designated as safety issue: No ]Subjects with at least one causative organism identified in the pre-therapy culture or a postive 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.
- 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 ] [ Designated as safety issue: No ]Subjects with at least one causative organism identified in the pre-therapy culture or a postive 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.
- Number of Subjects Who Received Alternative Medicine [ Time Frame: Up to 42 days after end of treatment ] [ Designated as safety issue: No ]As alternative medicine any systemic antibacterial medication was considered.
| Enrollment: | 460 |
| 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 |
|---|---|
|
Experimental: Moxifloxacin
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
|
Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
|
|
Active Comparator: Levofloxacin plus Metronidazole
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
|
Drug: Levofloxacin & Metronidazole
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) 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, Liaoning | |
| Shenyang, Liaoning, China, 110004 | |
| China, Sichuan | |
| Chengdu, Sichuan, China, 610041 | |
| China | |
| Beijing, China, 100034 | |
| Beijing, China, 100083 | |
| Chongqing, China, 400010 | |
| Shanghai, China, 200011 | |
| Indonesia | |
| Jakarta, Indonesia | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 133792 | |
| Pakistan | |
| Karachi, Pakistan | |
| Philippines | |
| Manila, Philippines | |
| Taiwan | |
| Taipei, Taiwan, 10002 | |
| Taizung, Taiwan, 402 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
Publications:
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00453349 History of Changes |
| Other Study ID Numbers: | 11981, 2006-000874-56 |
| Study First Received: | March 27, 2007 |
| Results First Received: | September 1, 2009 |
| Last Updated: | November 8, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Bayer:
|
Uncomplicated pelvic inflammatory disease |
Additional relevant MeSH terms:
|
Pelvic Inflammatory Disease Pelvic Infection Infection Adnexal Diseases Genital Diseases, Female Metronidazole Moxifloxacin Ofloxacin Norgestimate, ethinyl estradiol drug combination Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013