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NCT00473460 · ClinicalTrials.gov registry record · Phase 3
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,404
- Enrollment target
NCT00473460 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,404 participants.
The verdict
NCT00473460, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,404 participants
- Enrollment target
Study Summary
Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group
Interventions
- DRUG Placebo
- DRUG Avelox (Moxifloxacin, BAY12-8039)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,404 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00473460
The ClinicalTrials.gov registry entry for NCT00473460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,404 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00473460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00473460 about?
NCT00473460 is a clinical study titled "Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis". Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate...
What is the current status of trial NCT00473460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,404 participants. The study started on 2004-10. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00473460?
The interventions under investigation include: Placebo (DRUG), Avelox (Moxifloxacin, BAY12-8039) (DRUG).
Who is sponsoring clinical trial NCT00473460?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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