Clinical trial NCT02639520 (phase 3, status: completed)
Conditions: urinary tract infection
ICD codes: P39.3, N39.0, O86.20, O86.29, N99.531, O03.38, N99.521
Drugs: canephron® n, fosfomycin trometamol, canephron® n-placebo, fosfomycin trometamol-placebo
SMILES: C[C@@H]1O[C@@H]1P(O)(O)=O, C[C@@H]1O[C@@H]1P(O)(O)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent (IC) and data protection declaration

          2. Female outpatients aged 18 to 70 years

          3. Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on
             the Acute Cystitis Symptom Score (ACSS)-"Typical" domain at Visit 1 is ≥6

          4. Symptoms of the acute episode of lower uUTI are developed within not more than 6 days
             prior to Visit 1

          5. Leukocyturia at Visit 1, confirmed by positive dipstick

          6. Patients willing to refrain from consuming prohibited concomitant medications and
             products

          7. Non-lactating female patients who are surgically sterile (have had a documented
             sterilization, bilateral oophorectomy at least 3 months before the start of the trial
             and/or hysterectomy), or postmenopausal (cessation of menses for at least 12 months),
             or women of childbearing potential with a negative pregnancy test at Visit 1 willing
             to use highly effective (failure rate less than 1% per year, i.e., Pearl Index <1)
             contraception methods, e.g., contraceptive patch, oral, injected or implanted hormonal
             methods of contraception, during the trial including the follow-up period.

        Exclusion Criteria:

          1. Any signs of complicated urinary tract infections (UTIs), pyelonephritis (i.e., fever
             T ≥38.0°C [grade 2], flank and/or back pain, chills and shivers), and/or
             vulvo-vaginitis with vaginal and/or with urethral discharge (without urination) at
             Visit 1.

          2. Any conditions that may lead to complicated infections (i.e., renal diseases, urinary
             tract abnormalities or past urinary surgery, urine catheterization, uncontrolled
             diabetes mellitus, spinal cord injury, etc.).

          3. Chronic infection of the urinary tract known from medical history.

          4. Persisting signs or symptoms of severe, progressive, or uncontrolled systemic disease
             (i.e., renal, hepatic, biliary, hematological, gastro-intestinal, endocrine,
             pulmonary, cardiac, neurological, or cerebral disease).

          5. Uncontrolled hypertension (a diastolic blood pressure >95 mmHg at Visit 1).

          6. Known severe cardiac insufficiency, coronary heart disease, valvular heart disease,
             cardiac arrhythmia, QT interval prolongation or other severe cardiac disease at Visit
             1.

          7. Any antibiotic therapy within 30 days prior to Visit 1.

          8. Other acute infections (except uUTIs) requiring antibiotic treatment at Visit 1.

          9. Patients receiving treatment for suspected or confirmed UTI (antibiotic or
             phytopharmaceutical) within 30 days prior to Visit 1.

         10. Patients who took anti-inflammatory drugs (e.g., ibuprofen) or spasmolytics for any
             reason within 24 hours prior to Visit 1, and/or are not willing to stop the intake of
             any of the medication not permitted for use during the trial.

         11. Known severe impaired renal function (creatinine clearance <20 mL/min).

         12. Active peptic ulcers.