Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections (EMERON)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668122
First received: April 24, 2008
Last updated: June 29, 2009
Last verified: June 2009

April 24, 2008
June 29, 2009
March 2004
Not Provided
Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
The primary efficacy variable was the bacteriological response 5 to 9 days after the last dose of study medication (TOC visit). [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00668122 on ClinicalTrials.gov Archive Site
  • Bacteriological outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Bacteriological outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Clinical outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Clinical outcome at the test-of-cure visit [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
  • Clinical outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Adverse event collection [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Bacteriological outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Bacteriological outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Clinical outcome during treatment [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
  • Clinical outcome at the test-of-cure visit [ Time Frame: 5-9 days ] [ Designated as safety issue: No ]
  • Clinical outcome at follow-up [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 28-42 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Efficacy and Safety of Ciprofloxacin Extended-Release 1000 mg Once-Daily Versus Ciprofloxacin Immediate-Release 500 mg Twice-Daily Given 7-14 Days in Patients With Complicated Urinary Tract Infections: Prospective, Randomized, Double-Blind Trial.

To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Tract Infection
  • Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
    Ciprofloxacin XR 1000 mg orally once a day
  • Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
    Ciprofloxacin IR 500 mg orally twice a day
  • Experimental: Arm 1
    Intervention: Drug: Cipro XR (Ciprofloxacin, BAYQ3939)
  • Experimental: Arm 2
    Intervention: Drug: Cipro IR (Ciprofloxacin, BAYQ3939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
212
January 2006
Not Provided

Inclusion Criteria:

The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:

  • One or more clinical symptoms and signs of a lower UTI: fever (> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
  • One or more of the following underlying conditions suggestive of cUTI:
  • Indwelling urinary catheter.
  • 100 mL of residual urine after voiding.
  • Neurogenic bladder.
  • Obstructive uropathy due to lithiasis, tumor or fibrosis.
  • Acute urinary retention in men.

Exclusion Criteria:

Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).

  • Have a history of allergy to quinolones
  • Are unable to take oral medication
  • Have an intractable infection requiring > 14 days of therapy
  • Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
  • Have prostatitis or epididymitis
  • Have had a renal transplant
  • Have ileal loop or vesica- urethral reflux
  • Have significant liver or kidney impairment
  • Have a history of tendinopathy associated with fluoroquinolones
  • Are pregnant, nursing
  • Have a history of convulsions or CNS disorders
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00668122
11454
No
Therapeutic Area Head, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP