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Urinary Tract InfectionPhase 4NCT00669994

Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections

A Phase 4 study testing Ciprofloxacin in people with Urinary Tract Infection, run by Bayer at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated. Read more about this study

Who is it for?
Ages 18 to 44 years, women only
Conditions the study is for
Urinary Tract Infection
What is being tested?
Ciprofloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
31 sitesUnited States
Study dates
Jul 2003to Oct 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 44 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Non-pregnant, non-lactating female outpatients between the ages of 18 - 44 years (inclusive)
  • Patients with at least two of the following clinical signs and symptoms of an uUTI:
  • Dysuria
  • Frequency
  • Urgency
  • Suprapubic pain
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  • Patients with onset of symptoms < 72 hours prior to study entry
  • Patients with one positive pre-treatment clean-catch midstream urine culture at enrollment in the study, defined as > 10000 CFU/mL (study drug treatment is permitted prior to the availability of urine culture results)
  • Positive leukocyte esterase (LE) (1+ or greater) utilizing a urine dipstick method of analysis
  • Patients willing to give written informed consent
  • Cultures must be performed on pre-treatment clean-catch midstream urine (MSU) specimens

Who cannot join

  • Males
  • Women who are pregnant, nursing, or not using two medically accepted, effective methods of birth control
  • Patients with known or suspected hypersensitivity to quinolones
  • Patients unable to take oral medication for any reason
  • Patients with an asymptomatic bacteriuria
  • Patients with complicated UTI, defined as: a clinical syndrome characterized by the development of systemic and local signs and symptoms of fever (> 38.3°C/101°F orally), chills, malaise, flank pain, back pain, or costovertebral angle (CVA) pain or tenderness
Show all 19Show fewer
  • Symptoms as outlined in the inclusion criteria occurring in the presence of a functional or anatomical abnormality of the urinary tract or in the presence of urinary catheterization
  • Patients with symptoms of a UTI within the 4 weeks prior to the present episode
  • Patients with the onset of symptoms >72 hours prior to study entry
  • Patients with three or more episodes of any UTI in the past 12 months
  • Patients with evidence of factors predisposing to the development of UTIs, including calculi, stricture, primary renal disease (e.g. polycystic renal disease), or neurogenic bladder
  • Patients who received systemic antimicrobial therapy within 48 hours prior to entry
  • Patients with a neutrophil count < 1000/mm3, CD4 < 200/mm3 or other conditions associated with significant depression in host defense; HIV testing is not mandatory
  • Patients requiring concomitant systemic antibacterial therapy with agents not specified in this protocol
  • Patients with a previous history of tendinopathy associated with fluoroquinolones
  • Patients diagnosed with a rapidly fatal underlying disease (death expected within six months)
  • Patients requiring concomitant use of theophylline
  • Patients previously enrolled in this clinical study
  • Patients taking an investigational drug in the last 30 days

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Study site

    Avon, Connecticut, 06001

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Camillus, New York, 13031

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Elizabeth, New Jersey, 07202-3672

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Feasterville, Pennsylvania, 19053

  • Study site

    Hatboro, Pennsylvania, 19040

  • Study site

    Holmdel, New Jersey, 07733

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Long Beach, California, 90806

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Milford, Massachusetts, 01757

  • Study site

    Murray, Utah, 84107

  • Study site

    Pelham, Alabama, 35124

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Royal Oak, Michigan, 48073-6769

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Diego, California, 92182-4701

  • Study site

    San Luis Obispo, California, 93401

  • Study site

    San Mateo, California, 94403-4398

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Sylmar, California, 91342

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: Prospective, Open Label Non-comparative, Multi-center Trial to Evaluate the Efficacy and Safety of Cipro® XR 500 mg Once Daily for 3 Days in Treating Female Patients With Acute, Uncomplicated, Symptomatic Lower Urinary Tract Infections

This trial evaluated how effective and safe Cipro XR was in treating female patients with signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was eliminated.

Being tested
Ciprofloxacin
Keywords
UTI, Urinary Tract Infection
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.

  • CiprofloxacinDrug

    Cipro XR 500 mg tablets taken once daily

Study groups in NCT00669994
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Ciprofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bacteriologic outcome in patients with UTI caused by S. saprophyticus

    Measured: 4-11 days post-treatment

Secondary outcomes (3)

  1. Adverse Events Collection

    Measured: Up to 4-11 days post-treatment

  2. Clinical Response

    Measured: 4-11 days post-treatment

  3. Incidence of premature terminations

    Measured: Premature discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2008 (estimated)
  2. Study startJul 2003
  3. Study completionOct 2003

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669994
Sponsor's protocol ID
100546
Status last verified
Dec 2014
First submitted
29 Apr 2008
Last updated
19 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofloxacin in people with Urinary Tract Infection, run by Bayer at 31 sites in United States.

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 11 inclusion and 19 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 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Bacteriologic outcome in patients with UTI caused by S. saprophyticus (time frame: 4-11 days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669994.

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 19 Dec 2014.

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