Acute lower uncomplicated urinary tract infection MedDRA version: 20.0 Level: LLT Classification code 10024981 Term: Lower urinary tract infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Canephron® N
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ROSEMARY LEAF, pulv.
Other descriptive name: ROSEMARY LEAF
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion 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 three main uUTI symptoms (dysuria [“feeling pain or burning when passing urine”, No.3], pollakisuria [“frequent urination of small volumes of urine”, No. 1], and urgency [“Urgent urination”, No. 2]) reported on the 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 =65 years) yes F.1.3.1 Number of subjects for this age range 161
Exclusion criteria
Exclusion criteria: 1. Any signs of complicated 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 or analgesic drugs (e.g. ibuprofen, paracetamol, acetylsalicylic acid) 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 following medication not permitted for use during the trial: Rosmarini folium, Levistici radix, and Centaurii herba supplements other than the CLR (IMP), anti-inflammatory or analgesic drugs (e.g. ibuprofen, acetylsalicylic acid, with exception of paracetamol), spasmolytics, herbal drugs or supplements, cranberry juice, and kidney or bladder teas. 11. Known severe impaired renal function (creatinine clearance <20 mL/min). 13. Active peptic ulcers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of a non-antibiotic therapy with CLR versus an antibiotic treatment with fosfomycin trometamol in women suffering from acute lower uUTIs as measured by the proportion of patients who received an additional antibiotic treatment for acute lower uUTIs during the trial.;Secondary Objective: The secondary objective of this trial is to provide further efficacy data supporting the primary efficacy analysis and assess safety and tolerability of CLR for the treatment of acute lower uUTIs.;Primary end point(s): The primary efficacy endpoint is the intake of any additional antibiotic medication for acute lower uUTIs between Visit 1 and Visit 4.;Timepoint(s) of evaluation of this end point: See E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Intake of an antibiotic treatment for acute lower uUTI in addition to the trial treatment by reason of persistent symptoms (assessed by investigator) between Visit 1 and Visit 4. 2. Intake of an antibiotic treatment for acute lower uUTI in addition to the trial treatment by reason of recurrent symptoms (assessed by investigator) between Visit 1 and Visit 4. 3. Efficacy endpoints based on ACSS questionnaire assessments at Visit 2, Visit 3 and Visit 4, including: o Severity of each uUTI symptom reported on the ACSS-”Typical” domain o Sum-score of the ACSS-”Typical” domain o Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the ACSS-”Typical” domain o Clearance of the uUTI symptoms reported on the ACSS-”Typical” domain (clearance is observed when none of the uUTI symptoms is >1) o Clinical change (clinical cure, improved, clinical failure) o Clinical cure = Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the ACSS-”Typical” domain is =3 and none of the symptoms is >1 o Clinical failure = Sum-score of the main uUTI symptoms (dysuria, pollakisuria, and urgency) reported on the ACSS-”Typical” domain is =6 o Improved = Patients which meet neither the criteria of clinical cure nor the criteria of clinical failure o ACSS-”Dynamics” domain score o Single-item scores of the ACSS-”Quality of life” domain o Sum-score of the ACSS-”Quality of life” domain 4. Amount of bacteriuria (in CFU/mL) at Visit 3 and Visit 4. 5. Significant bacteriuria (=103 CFU/mL), non significant bacteriuria, and unknown bacteriuria (meaning that microbiological tests were not available for a certain reason, e.g. too small urine sample) at Visit 1, Visit 3 and Visit 4. 6. Leukocyturia (positive dipstick) at Visit 3 and Visit 4. 7. Paracetamol intake for acute lower uUTI symptoms from Visit 1 to Visit 4. 8. Investigator’s and patient’s overall assessment of efficacy at Visit 3 and Visit 4 | — |
Countries
Germany, Ukraine
Contacts
Public ContactClinical Research Department
Bionorica SE
Outcome results
None listed