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Clinical Trials/EUCTR2007-007742-35-DE
EUCTR2007-007742-35-DE
Active, not recruiting
Not Applicable

A double-blind, double-dummy, prospective, randomized multiple-site study of oral Finafloxacin 300 mg b.i.d. versus oral Ciprofloxacin 250 mg b.i.d. in patients with lower uncomplicated UTI (uUTI) with a treatment duration of 3 days. - FLUT

MerLion Pharmaceuticals GmbH0 sites48 target enrollmentMarch 25, 2008
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Conditionsower uncomplicated Urinary Tract InfectionMedDRA version: 9.1Level: LLTClassification code 10046571Term: Urinary tract infection
DrugsCiprofat 250 mg

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ower uncomplicated Urinary Tract Infection
Sponsor
MerLion Pharmaceuticals GmbH
Enrollment
48
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 25, 2008
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Female patients between 18 and 55 years with uUTI.
  • •2\.Two of the following sign and symptoms of uUTI: dysuria, frequency, urgency, miction pain, suprapubic pain, gross hematuria, turbid urine or malodorous urine.
  • •3\.Able to supply a mid\-stream, clean catch urine sample for microbiological analysis.
  • •4\.The result of the dipstick should indicate a high probability of the required number of bacteria.
  • •5\.Be able to communicate with the study personnel.
  • •6\.Has given written consent to participate in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Female patients having signs and symptoms of upper urinary tract infection (e.g. fever, flank pain) indicating complicated UTI.
  • •2\.Male patients
  • •3\.History or evidence of other functional or anatomical abnormalities of the urinary tract (e.g. acute pyelonephritis), diabetes mellitus and immunosuppresion.
  • •4\.Recurrent cystitis with more than 3 episodes in the past 12 months.
  • •5\.Clinical symptoms for more than 7 days before Baseline.
  • •6\.Psychiatric, neurological or behaviour disorders.
  • •7\.Clinically significant serious unstable physical illness.
  • •8\.Known uncontrolled condition of hypertension or symptomatic hypotension, known ischemic heart disease or history of myocardial infarction (within 12 months prior study enrolment), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
  • •9\.Existence of any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
  • •10\.Antibiotic intake 2 weeks before study enrolment.

Outcomes

Primary Outcomes

Not specified

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