Urinary Tract InfectionsPhase 4EXPRESSNCT00663806
A Phase IV Study of Cipro XR in Uncomplicated UTI
A Phase 4 study testing Cipro XR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infections, run by Bayer.
Trial summary
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cipro XR (Ciprofloxacin, BAYQ3939)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,614 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jul 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
- Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
- Willing to give written consent.
Who cannot join
- Pregnant or nursing
- Complicated UTI
- Allergy to Cipro XR
About this study
Official title: EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.
- Conditions
- Urinary Tract Infections
- Being tested
- Cipro XR (Ciprofloxacin, BAYQ3939)
- Keywords
- UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cipro XR (Ciprofloxacin, BAYQ3939)Behavioural
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI
Cipro XR (Ciprofloxacin, BAYQ3939)Behavioural
Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) |
| Arm 2 | Experimental | Not described Receives: Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.
Measured: 3-10 days after start of therapy
Secondary outcomes (2)
To examine the difference between physician and patient perceptions of the symptoms of uUTI.
Measured: At baseline visit pre-therapy
To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.
Measured: 1-3 days after end of therapy for efficacy and up to 30 days for safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,614 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
- NCT00663806
- Sponsor's protocol ID
- 100534
- Acronym
- EXPRESS
- Status last verified
- Dec 2014
- First submitted
- 17 Apr 2008
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPRESS: Evaluating Cipro XR Patient Response, Education, Safety, and Satisfaction
- ClinicalTrials.gov ID
- NCT00663806
- Acronym / sponsor ID
- EXPRESS / 100534
- Conditions
- Urinary Tract Infections
- Keywords
- UTI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,614 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Jul 2003 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of Cipro XR in a naturalistic setting and the effectiveness of an educational brochure. - Women with urinary tract infections were treated with Cipro XR. They were also given a brochure with information about urinary tract infections and later tested on the information.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) |
| Arm 2 | Experimental | Behavioral: Cipro XR (Ciprofloxacin, BAYQ3939) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ambulatory women outpatients 18 to 65 years of age with a documented clinical diagnosis of uUTI characterized by dysuria with either urgency or frequency. Women of childbearing age were enrolled only if they were highly unlikely to conceive during the study and were practicing a suitable method of birth control or were at least 1 year postmenopausal.
- Positive leukocyte esterase (>/= 1+) and positive nitrite test using a urine dipstick method of analysis.
- Willing to give written consent.
Key exclusion criteria (3 listed)
- Pregnant or nursing
- Complicated UTI
- Allergy to Cipro XR
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 |
|---|---|---|
| Cipro XR (Ciprofloxacin, BAYQ3939)Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days and brochure about UTI | Behavioural | Arm 1 |
| Cipro XR (Ciprofloxacin, BAYQ3939)Received Cipro XR (Ciprofloxacin, BAYQ3939) 500 mg once daily for 3 days; not given brochure about UTI | Behavioural | Arm 2 |
Primary outcome
To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure.
Time frame: 3-10 days after start of therapy
2 secondary outcomes
To examine the difference between physician and patient perceptions of the symptoms of uUTI.
Time frame: At baseline visit pre-therapy
To collect data on the clinical efficacy and safety of Cipro XR, 500 mg, PO once daily, for 3 days, in the treatment of uUTI in a naturalistic setting.
Time frame: 1-3 days after end of therapy for efficacy and up to 30 days for safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cipro XR (Ciprofloxacin, BAYQ3939) in people with Urinary Tract Infections, run by Bayer.
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 3 inclusion and 3 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare the effect on knowledge of uncomplicated urinary tract infection (uUTI) in patients who were given a disease-directed educational brochure to read versus patients who were not given the brochure. (time frame: 3-10 days after start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2014.