Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI)
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Intervention: Canephron® N
Intervention description: 3x 2 coated tablets/day for 7 days p.o.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of the study is to assess safety and impact of a non-antibiotic therapy
      approach with Canephron® N in the management strategy of uncomplicated lower urinary tract
      infections (UTIs).
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Female outpatients aged 18-65 years (both inclusive).

          -  Patients suffering of symptoms of uncomplicated lower urinary infection at screening.
             Patients must have a total sum score of at least six for the symptoms dysuria,
             frequency and urgency.

          -  Development of symptoms within a maximum of 6 days before screening.

          -  Willing to refrain from consuming prohibited concomitant medications and products.

          -  Non-lactating female patients, who are surgically sterile (have had a documented
             bilateral oophorectomy and/or hysterectomy) or postmenopausal (cessation of menses for
             more than 1 year), or patients of childbearing potential with a negative pregnancy
             test at screening willing to use effective contraception methods (intrauterine device
             [IUD], hormonal contraceptives) during the study.

        Main Exclusion Criteria:

          -  Any signs evoking complicated UTI, pyelonephritis and/or concomitant vulvo-vaginitis

          -  Any conditions that may lead to complicated infections (that is, renal diseases,
             urinary tract abnormalities or past urinary surgery, urine catheterization, etc).

          -  Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP),
             ultrasound or cystoscopy.

          -  Current signs or symptoms of severe, progressive or uncontrolled life-threatening
             systemic disease i.e. renal, hepatic, haematological, gastrointestinal, endocrine,
             pulmonary, cardiac, neurological, or cerebral disease.

          -  Other acute infection (except UTI) requiring antibiotic treatment.

          -  Patients receiving treatment for presumed or proven urinary tract infection within 4
             weeks prior to study entry.

          -  Antibiotic, immunosuppressive or immunostimulant (incl. vaccines) therapy within 4
             weeks prior to study entry.

          -  Patients with known history of anatomical genitourinary (GU) anomalies or GU surgery
             within 6 months prior to study entry.

          -  Patients with known clinically significant abnormalities in screening physical
             examination, laboratory tests or vital signs.

          -  Peptic ulcers and hypersensitivity and/or idiosyncrasy to centaury herb, lovage root,
             rosemary leaves or one of the other ingredients of the investigational medicinal
             product.

          -  Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or
             sucrase-isomaltase insufficiency, galactose intolerance or lactase deficiency.

          -  Patients with a history of severe drug allergy or hypersensitivity.

          -  Known Human Immunodeficiency Virus (HIV)-seropositivity.