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NCT00481689 · ClinicalTrials.gov registry record · Phase 4
Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
NCT00481689 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 500 participants.
The verdict
NCT00481689, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
Study Summary
Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat complicated urinary tract infections caused by Pseudomonas aeruginosa. The study doctor will also gather information about using Cipro XR to treat complicated urinary tract infections caused by other bacteria. About 500 people with complicated urinary tract infections who are 18 years old and older will join this study. Cipro XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of complicated urinary tract infections and acute uncomplicated pyelonephritis (inflammation of the kidney). The dose of Cipro XR used in this study (1000 mg a day for 7 to 14 days), has been shown to be safe and effective. This study is being done to gather more information on using this dose of Cipro XR for complicated urinary tract infections caused by Pseudomonas aeruginosa, as well as by other bacteria.
Interventions
- DRUG Cipro XR (Ciprofloxacin, BAYQ3939)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2004-05 |
| Est. Completion | 2005-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00481689
The ClinicalTrials.gov registry entry for NCT00481689 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 500 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 1 intervention - of which Cipro XR (Ciprofloxacin, BAYQ3939) is the first listed.
NCT00481689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00481689 about?
NCT00481689 is a clinical study titled "Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens". Researchers want to find out if a drug called Cipro® XR (ciprofloxacin extended-release) can help people with a complicated urinary tract infection caused by a kind of bacteria called Pseudomonas aeruginosa. The study doctor will give Cipro XR to some people to see if it is safe and works to treat c...
What is the current status of trial NCT00481689?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2004-05. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00481689?
The interventions under investigation include: Cipro XR (Ciprofloxacin, BAYQ3939) (DRUG).
Who is sponsoring clinical trial NCT00481689?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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