check_circleStudy Completed
Pelvic Inflammatory Disease
Bayer Identifier:infoA unique number for a trial given by Bayer.
11981
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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
FemaleAge
18 YearsTrial summary
Enrollment Goal info
460The overall number of participants needed for a trial.
Trial Dates info
January 2007 - May 2008Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Avelox (Moxifloxacin hydrochloride, BAY12-8039)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
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 Hospital | Taipei, 10002, Taiwan |
Completed | Chung Shan Medical University Hospital | Taizung, 402, Taiwan |
Completed | Mahidol University | Bangkok, 10700, Thailand |
Completed | Peking University Third Hospital | Beijing, 100083, China |
Completed | West China Hospital, Sichuan University | Chengdu, 610041, China |
Completed | 2nd Hosp., Chongqing Medical Univ. | Chongqing, 400010, China |
Completed | Bunda Hospital | Jakarta, Indonesia |
Completed | HanYang University Medical Center | Seoul, 133792, Korea, Republic Of |
Completed | Philippine General Hospital | Manila, Philippines |
Completed | Ziauddin Medical University Hospital | Karachi, Pakistan |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Populationdate_rangeTime Frame:7 - 14 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Populationdate_rangeTime Frame:7 - 14 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
- Clinical Response on Treatment for Per Protocol Populationdate_rangeTime Frame:4 - 7 days after start of therapyenhanced_encryptionNoSafety Issue:
- Clinical Response on Treatment for Intent To Treat Populationdate_rangeTime Frame:4 - 7 days after start of therapyenhanced_encryptionNoSafety Issue:
- Bacteriological Response at Test Of Cure (TOC) visit microbiologically validdate_rangeTime Frame:7 – 14 days at TOC visitenhanced_encryptionNoSafety Issue:
- Bacteriological Response at Test Of Cure (TOC) visit in Intent To Treat population with causative organismdate_rangeTime Frame:7 – 14 days at TOC visitenhanced_encryptionNoSafety Issue:
- Clinical Response at follow-up visit on Per Protocol populationdate_rangeTime Frame:28 – 42 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
- Clinical Response at follow-up visit on Intent To Treat populationdate_rangeTime Frame:28 – 42 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
- Bacteriological Response at follow-up visit microbiologically validdate_rangeTime Frame:28 – 42 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
- Bacteriological Response at follow-up visit in Intent To Treat population with causative organismdate_rangeTime Frame:28 – 42 days after completion of study drug therapyenhanced_encryptionNoSafety Issue:
- Number of subjects who received alternative medicinedate_rangeTime Frame:up to 42 days after end of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Double Blind“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.